Many surgical mesh vicims are seeking justice and accountability as a result of allegedly defective Bard Ventralight ST mesh and the Bard Ventralight ST hernia Patch. On September 14, 2017 Julio Nunez of Randolph County, North Carolina filed a Ventralight ST Hernia Patch lawsuit against C.R. Bard Inc. and Bard Davol Inc. in the United States District Court for the District of New Jersey. Julio Nunez, hereinafter, the ventralight mesh victim, hired some of the best hernia mesh lawyers in the United States to seek justice and accountability from Bard Davol on account of allegedly defective hernia mesh. It is apparent from the Ventralight lawsuit that Julio Nunez filed that Nunez is ‘in it to win it’ and is not seeking any average hernia mesh lawsuit settlement amount.

In 2018, another Ventralight victim, Robert Prater, sought Justice and compensation in Federal Court against C.R. Bard and their Subsidiary Davol Inc. This Ventralight mesh article tells the story of these two victims.

What is Bard Ventralight™ ST Mesh?

“Uncoated lightweight monofilament polypropylene mesh on the anterior side with an absorbable hydrogel barrier based on Sepra® Technology on the posterior side for laparoscopic ventral hernia repair.”  Bard 

What is a Ventralex™ ST Hernia Patch

“A clinically proven umbilical hernia repair solution designed for ventral, incisional, umbilical and epigastric hernia repair as well as trocar site closure, with an absorbable barrier featuring Sepra®technology.” Id.

Prater Ventralight ST Bard mesh lawsuit

On July 18, 2018 Robert Prater of Ohio filed a Ventralight ST Bard mesh lawsuit against DAVOL, INC. located at 100 Sockanosset Crossroad Cranston, Rhode Island 02920. He also filed a lawsuit against C.R. BARD, INC. located at 730 Central Avenue Murray Hill, New Jersey 07974. This ventralight ST Bard mesh lawsuit was filed in UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF OHIO for the EASTERN DIVISION. Mr. Prater sought to serve a bigwig at Davol, listed on the summons as: Davol, Inc. C/O Daniel LaFever, President 100 Sockanosset Crossroad  Cranston, Rhode Island 02920. The nature of the suit was under the larger umbrella of “TORTS” and the category of “Health Care, Pharmaceutical, Personal Injury and Product Liability.” Since this was a “diversity case” The Plaintiff was a Citizen of This State (Ohio). The Defendant was “Incorporated and Principal Place of Business In Another State. Ventralight hernia mesh lawsuit.

The summons indicated “A lawsuit has been filed against you. Within 21 days after service of this summons on you (not counting the day you received it) — or 60 days if you are the United States or a United States agency, or an officer or employee of the United States described in Fed. R. Civ. P. 12 (a)(2) or (3) — you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff or plaintiff’s attorney,
whose name and address are: Id.

What relief is Mr. Prater seeking:

According to the Ventralight lawsuit filed by Robert Prater, he is seeking the following damages:

“Compensatory damages to Plaintiff for past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by Plaintiff, permanent impairment, mental pain and suffering, loss of enjoyment of life, health and medical care costs, economic damages, together with interest and costs as provided by law;
ii. Restitution and disgorgement of profits;
iii. Punitive damages;
iv. Reasonable attorneys’ fees as provided by law;
v. Past and future cost of all proceedings;
vi. All ascertainable economic damages;
vii. Prejudgment interest on all damages as allowed by law; and
viii. Such other and further relief as this Court deems just and proper.”

 

Robert Prater hernia mesh lawsuit| BARD VENTRALIGHT ST MESH

ROBERT PRATER sought justice and compensation against  C.R. Bard and Davol Inc. as a result of allegedly defective Ventralight ST Bard Mesh. His surgical mesh lawsuit was filed on July 18, 2018, in the UNITED STATES DISTRICT COURT for the NORTHERN DISTRICT OF OHIO, EASTERN DIVISION. The victim alleged that he “suffered permanent injuries and significant pain and suffering, emotional distress, lost wages and earning capacity, and diminished quality of life.” Id.

It all started on January 24th, 2013 when Mr. Prater, the ventralight victim, sought medical treatment for  “…a mesh procedure and underwent ventral hernia repair by Dr. Joseph Yurich at St. Elizabeth Boardman Health Center in Youngstown, Ohio. A 4” x 6” Ventralight ST Bard Mesh, Cat No. 5954460 Lot No. HUWG0533 was implanted in Plaintiff during this repair.” Id. Ventralight Prater mesh complaint

Mr. Prater could have never known that he was embarking on a years long journey or misery and suffering that would culminate in a hernia mesh lawsuit. “On or about July 18, 2016, Plaintiff Robert Prater underwent explantation of a failed ST Bard Mesh by Dr. Joseph Yurich at St. Elizabeth Boardman Health Center in Youngstown, Ohio. Dr. Yurich noted that Robert Prater presented with “mesh poking its way out of the anterior abdominal wall as well as leaking ascitic fluid.” Id.

The mesh complications that necessitated the hernia mesh revision and  surgical mesh removal surgery was: “mesh poking its way out of the anterior abdominal wall as well as leaking ascitic fluid.” Id. The mesh lawsuit victim asserted,”The ST Bard Mesh “had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the ST Bard Mesh was initially implanted to treat.” Id.

According to Bard propaganda, “Ventralight™ ST Mesh -Uncoated lightweight monofilament polypropylene mesh on the anterior side with an absorbable hydrogel barrier based on Sepra® Technology on the posterior side for laparoscopic ventral hernia repair.”

What did Mr. Prater allege was wrong with Ventralight ST mesh?

Mr. Prater retained a top-notch hernia mesh law firm who embarked on ‘the fight of their life’ against deep pocketed big corporate America. This is not Bard / Davol’s first rodeo into high stakes hernia mesh defective product liability litigation. Avid readers of the mesh lawsuit blog know that Bard plead guilty to 391 felonies related to defective heart catheters.  A few of Bard Davol’s executives spent time in the slammer for their felonious conduct. Also, Bard settled 2600 lawsuits related to Kugel hernia mesh lawsuits for 184 million.  Approximately 1500 hundred lawsuits were filed in Rhode Island state court against Bard Davol. Many hernia mesh attorneys are trying to take advantage of the nearly endless statute of limitations available to Bard Davol hernia mesh victims in Rhode Island. Additionally, there is a strong probability that there will be a Federal Court multidistrict litigation against Bard Davol related to all Bard hernia mesh products.  In this Federal Court hernia mesh lawsuit, the victims hernia mesh lawyers pulled no punches and laid it all on the line. Mr. Prater’s hernia mesh lawyers explained in great detail why they believe Ventralight ST Mesh is dangerous and defective. The hernia mesh law firm appears to be focusing on the ST coating that ventralight is composed of as well as the polyproplene the mesh is comprised of. Below are some of those details from the Prater hernia mesh complaint.

  • “The ST coating, which is not used in any other hernia mesh product sold in the United States, incites an intense inflammatory
    response, leading to encapsulation, deformation, scarification and contraction, migration, erosion and rejection.” Id.
  • “The impermeable ST coating leads to seroma formation, and provides a breeding ground for infection, and protects bacteria from being eliminated by the body’s natural immune response.” id.

Polyproplene mesh: “in itself dangerous and defective”

The surgical mesh attorneys did not only argue that the ST coating on ventralight ST mesh was dangerous but the coating degraded over a long period of time causing polypropylene mesh to be exposed to  the human tissue. The ventralight mesh attorneys asserted that the Polyproplene in Ventralight was “substandard” and dangerous and could cause bowel perforation or adhesion mesh complications. Here are some of he most explosive allegations in the Prater hernia mesh lawsuit.

  • “This ST coating also caused immunogenic response, and was known to be cytotoxic. 54. The coating of the ST Bard Mesh, which was marketed, promoted and intended as a barrier against adhesion to the bowel, was only temporary; it was expected and intended to degrade over time inside the body. Thus, this coating prevented tissue ingrowth in the short term, and degraded in the long-term, eventually leaving the “naked” polypropylene mesh and PGA exposed to the internal viscera and tissues.” Id.
  • “Once exposed to the viscera, the polypropylene and PGA will inevitably adhere to the viscera, initiating a cascade of adverse consequences. Any purported beneficial purpose of the coating (to prevent adhesion to the bowel and internal viscera) was non-existent; the product provided no benefit while substantially increasing the risks to the patient.” Id,
  • “The polypropylene mesh within the defective coating of the ST Mesh was in itself dangerous and defective, particularly when used in the manner intended by Defendants in the ST Bard Mesh. The particular polypropylene material used in the ST Bard Mesh was substandard, adulterated and non-medical grade, and was unreasonably subject to oxidative degradation within the body, further exacerbating the adverse reactions to the product once the ST coating mdegraded. When implanted adjacent to the bowel and other internal organs, as Defendants intended for ST Bard Mesh, polypropylene mesh is unreasonably susceptible to adhesion, bowel perforation or erosion, fistula formation and bowel strangulation or hernia incarceration, and other injuries.” Id.
  • “The appropriate treatment for complications associated with ST Bard Mesh involves additional invasive surgery to remove the mesh from the body, thus eliminating any purported benefit that the mesh was intended to provide to the patient.” Id.
  • “The ST Bard Mesh was designed and intended for intraperitoneal implantation, which required the product to be placed in contact with internal organs, which unnecessarily increased the risks of adhesion, erosion, fistula formation, and other injuries.” Id.

Searches related to ventralight hernia mesh

  • ventralight mesh recall
  • ventralight mesh complications
  • ventralight mesh lawsuit
  • ventralight st mesh with echo positioning system
  • bard ventralight mesh lawsuit
  • bard ventralight st mesh recall
  • ventralight st mesh sizes
  • ventralight mesh price

A safer alternative?

Below you will find a brief overview of a particular area of product liability law. The issue is whether a hernia mesh victim is required to establish that the surgical mesh manufacturers had a feasible / reasonable alternative design to the allegedly defective hernia mesh.

A “large number of courts that have said that plaintiff must present proof of a reasonable or feasible alternative design. Some have done so by legislative mandate, but the large majority has done so by judicial decision.” Cornell Law Library Scholarship@Cornell Law: A Digital Repository Cornell Law Faculty Publications Faculty Scholarship Spring 2009 Manufacturer ‘s Liability for Defective Product Designs: The Triumph of Risk-Utility Aaron Twerski Brooklyn Law School, James A. Henderson Jr. Cornell Law School, james- henderson@lawschool.cornell.edu https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=1556&context=facpub 

“Pritchett, 512 F.3d at 1063, 1066 (plaintiff was not required to prove a reasonable alternative design though Court reversed summary judgment for defendant on grounds that there were several practical and safer alternative designs for ratchet mechanism); Skyjack, 512 F.3d at 443 446-48 (plaintiff’s testimony of a reasonable alternative design was not required though Court reversed summary judgment for defendant on grounds that there was a reasonable alternative design available for “scissors lift”). In two Missouri Appellate Court decisions, the courts did not require the plaintiffs to prove a reasonable alternative design but gave heavy credence to the availability of a reasonable alternative design. See Smith v. Brown & Williamson Tobacco Corp., 275 S.W.3d 748 Mo. Ct. App. 2008) (court upheld jury verdict for plaintiff on grounds that Kool Menthol cigarettes were unreasonably dangerous; plaintiff was not required to prove a reasonable alternative design though the court concluded that evidence demonstrated that specific design choices by defendant had the potential to affect plaintiff’s health during the time period she smoked); Thompson v. Brown & Williamson Tobacco Corp., 207 S.W.3d 76, 95-96 (Mo. Ct. App. 2006) (court found that plaintiff did not have to prove a reasonable alternative design and held that the evidence went beyond a categorical attack on cigarettes; there was sufficient evidence for the jury to conclude that the products were unreasonably dangerous as designed since plaintiff had submitted proof that tobacco companies made specific design choices that had the potential to affect plaintiff’s health during the time period he smoked).” Id.

The Prater mesh lawsuit allegation that Bard had a safer feasible alternative to ventralight ST Bard Mesh

Below you will find an excerpt from the Prater hernia mesh lawsuit related to the issue of safer alternative design.

  • “At the time the ST Bard Mesh was implanted in Plaintiff, there were safer feasible alternative designs for hernia mesh products, including but not limited to, a flat, non-coated, single-layer mesh placed away from the bowel.” Id.

When such an allegation is made in a surgical mesh lawsuit, hernia mesh attorneys handling cases on a national basis often review the Restatement of Torts, Third edition. Section two of the Restatement of torts explains the 3 types of product defects. Please review below:

§ 2. Categories of Product Defect

“A product is defective when, at the time of the sale or distribution, it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings. A product:

(a) contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product;

(b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe; Restatement (Third) of Torts: Products Liability” (2012) CHAPTER 1. LIABILITY OF COMMERCIAL PRODUCT SELLERS BASED ON PRODUCT DEFECTS AT TIME OF SALE TOPIC 1. LIABILITY RULES APPLICABLE TO PRODUCTS GENERALLY

Failure to warn allegations

Many inexperienced mesh attorneys focus only on the defective product liability aspect of hernia mesh lawsuits. These surgical mesh lawyers refuse to consider a failure to warn case or even a loss of consortium mesh cause of action. A design defect case is not the only show in town so to speak. Inadequate instructions and warning claims can also be successful in addition to defect cases for unreasonably dangerous products.   According to the Restatement of Torts 3rd, “A product can be defective in its manufacture or design, or because it fails to include a warning about known risks. (Rest.3d Torts, Products Liability, § 2.)

Lawyers who attended reputable laws schools and took product liability classes are well aware that the restatement of torts combines the common law of many states and provides the lowest common denominator.

“§ 2. Categories of Product Defect –A product is defective when, at the time of the sale or distribution, it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings. A product:……. (c) is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe.”  Restatement (Third) of Torts: Products Liability (2012)

“Is a product that is dangerous because it lacks adequate warnings or instructions.” (Brown, supra, 44 Cal.3d at 181*181 p. 1057; see Barker, supra, 20 Cal.3d at p. 428.) “Generally speaking, manufacturers have a duty to warn consumers about the hazards inherent in their products.” (Johnson, supra, 43 Cal.4th at p. 64.) A warning informs consumers about hazards of which they are unaware, so that they can avoid the product or minimize its danger by careful use. (Ibid.) In California, as in a majority of jurisdictions, liability for failure to warn is conditioned on the manufacturer’s actual or constructive knowledge of the risk. (Anderson, supra, 53 Cal.3d at p. 1000Brown, at p. 1066.) The duty to warn applies to all entities in a product’s chain of distribution. (See Taylor v. Elliott Turbomachinery Co. Inc. (2009) 171 Cal.App.4th 564, 575 [90 Cal.Rptr.3d 414].) Thus, like a manufacturer, a raw material supplier has a duty to warn about product risks that are known or knowable in light of available medical and scientific knowledge. (See Anderson, at pp. 1000, 1002.)

The “known or knowable” standard arguably derives from negligence principles (see Anderson, supra, 53 Cal.3d at pp. 1000-1001), and failure to warn claims are generally “`rooted in negligence’ to a greater extent than” manufacturing or design defect claims. (Id. at p. 1002; see Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1111-1112 [56 Cal.Rptr.2d 162, 920 P.2d 1347].) Unlike those other defects, a “`warning defect’ relates to a failure extraneous to the product itself” and can only be assessed by examining the manufacturer’s conduct. (Anderson, at p. 1002.) These principles notwithstanding, California law recognizes separate failure to warn claims under both strict liability and negligence theories.[6] In general, a product seller will be strictly liable for failure to warn if a warning was feasible and the absence of a warning caused the plaintiff’s injury. (Blackwell v. Phelps Dodge Corp. (1984) 157 Cal.App.3d 372, 377 [203 Cal.Rptr. 706]; see Anderson, at p. 1002.) Reasonableness of the seller’s failure to warn is immaterial in the strict liability context. (Anderson, at pp. 1002-1003.) Conversely, to prevail on a claim for negligent failure to warn, the plaintiff must prove that the seller’s conduct fell below the standard of care. (Id. at p. 1002.) If a prudent seller would have acted reasonably in not giving a warning, the seller will not have been negligent. (Id. at p. 1003.) Products liability plaintiffs often allege both design and warning defects. (See Anderson, supra, 53 Cal.3d at p. 995, fn. 7.) Here, the jury found no design defect. Accordingly, our opinion focuses on failure to warn.[7]

More Prater mesh allegations

  • “Plaintiff and Plaintiff’s physicians were unaware of the defects and dangers of ST Bard Mesh, and were unaware of the frequency, severity and duration of the risks associated with the ST Bard Mesh.” Id.
  • “The Defendants’ Instructions for Use provided with the ST Bard Mesh expressly understates and misstates the risks known to be associated specifically with the ST Bard Mesh by representing that the complications such as inflammation associated with the ST Bard Mesh as “possible complications.” Id.
  • “The ST Bard Mesh will always incite severe inflammation once implanted. The inflammation caused by the ST Bard Mesh is chronic in nature and systemic, not acute localized inflammation. No other surgical mesh sold in the United States has the dangerous and defective ST coating, which itself causes or increases the risks of numerous complications, including increased risk of seroma formation, immunologic response, increased risk for infection, and increased inflammatory reaction and foreign body response. Defendants provided no warning to physicians about the risks or increased risks specifically associated with the unique design of the ST Mesh.” Id.
  • “The Defendants’ Instructions for Use for the ST Mesh failed to adequately warn Plaintiff’s physicians of numerous risks which Defendants knew or should have known were associated with the ST Mesh, including the risks of the product’s immunologic response, pain, dehiscence, encapsulation, rejection, migration, scarification, contraction, adhesion to internal.” Id.
  • “The Defendants’ Instructions for Use for the ST Mesh failed to adequately warn Plaintiff’s physicians of numerous risks which Defendants knew or should have known were associated with the ST Mesh, including the risks of the product’s immunologic response, pain, dehiscence, encapsulation, rejection, migration, scarification, contraction, adhesion to internal organs and viscera, erosion through adjacent tissue and viscera, bowel obstruction, or hernia incarceration or strangulation.” Id.
  • “Defendants failed to adequately train or warn Plaintiff or Plaintiff’s physicians about the necessity for invasive surgical intervention in the event of complications, or how to properly treat such complications when they occurred.” Id.
  • “Defendants failed to adequately warn Plaintiff or Plaintiff’s physicians that the surgical removal of the ST Bard Mesh in the event of complications would leave the hernia unrepaired, the resulting hernia would be much larger than the original, and would necessitate further, more complicated medical treatment to attempt to repair the same hernia that the failed ST Mesh was intended to treat.” Id.
  • “Defendants represented to physicians, including Plaintiff’s physician, that the ST coating would prevent or reduce adhesions, and expressly intended for the ST Mesh to be implanted in contact with the bowel and internal organs and marketed and promoted the product for said purpose. Defendants failed to warn physicians that the ST coating was only temporary” Id.
  • “Defendants represented to physicians, including Plaintiff’s physician, that the ST coating would prevent or reduce adhesions, and expressly intended for the ST Mesh to be implanted in contact with the bowel and internal organs and marketed and promoted the product for said purpose. Defendants failed to warn physicians that the ST coating was only temporary and therefore at best would provide only a temporary adhesion barrier, and when the coating inevitably degraded, the exposed polypropylene and PGA would become adhered to the bowel or tissue.” Id.
  • “Defendants failed to warn Plaintiff and Plaintiff’s physicians that the ST Bard Mesh was considered a significant risk device by the FDA.” Id.
  • “Defendants marketed and continue to market the ST Bard Mesh in brochures and online without disclosing or making evident that PGA is utilized in the ST Bard Mesh.” Id.
  • “With respect to the complications that were listed in the Defendants’ warnings, Defendants provided no information or warning regarding the frequency, severity and duration of those complications, even though the complications associated with ST Bard Mesh were more frequent, more severe and lasted longer than those with safer feasible alternative hernia repair treatments.” Id.
  • “Defendants’ ST Bard Mesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the ST Bard Mesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; scarification; improper wound healing; excessive and chronic inflammation; allergic reaction; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tumor formation, cancer, tissue damage and/or death; and other complications.”Id.
  • “When affixed to the body’s tissue, the impermeable coating of the ST Mesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection or abscess formation and other complications.” Id.
  • “The ST coating provides an ideal bacteria breeding ground in which the bacteriacannot be eliminated by the body’s immune response, which allows infection to proliferate.” Id.

 

Nunez Ventralight ST hernia patch lawsuit

According to the Nunez Bard Ventralight lawsuit, the substance that Ventralight is composed of is “biogically incompatible” with the human body, more particularly the human tissue. The Ventralight mesh victim alleged that the Ventralight surgical patch caused him severe complications and very severe pain. Below you will find a detailed analysis of Julio Nunez’s ventralight hernia mesh lawsuit.

Allegations In the Julio Nunez Ventralight mesh lawsuit:

  • “The Plaintiff was operated on to repair a hernia, during which operation a variety
    of surgical mesh manufactured, sold and marketed by Defendants was implanted.
  • The surgical mesh used in the surgery was known as he “Ventralight ST Hernia
    Patch” (herein referred to as “Product”) and it was designed, manufactured, packaged, labeled,
    marketed, sold and distributed by Defendant.
  • The Product was made of materials which are biologically incompatible with
    human tissue and react negatively and sometimes dangerously with a large number of those on
    whom it is used.
  • Defendant knew or should have known that their Product was unreasonably
    harmful.
  • The scientific evidence Defendant knew or should have known of demonstrates
    that the mesh is incompatible with human tissue and often causes a negative immune response in
    patients implanted with the Product, including Plaintiff.
  • In April 2016, the FDA published an article on hernia mesh, identifying “pain,
    infection, hernia recurrence, adhesion and bowel obstruction” as the most common adverse
    events associated with hernia mesh implants, as well as other possible complications, like mesh
    migration and mesh shrinkage.
  • The Ventralight ST mesh is marketed to the medical community and to patients as
    a safe, effective, and reliable medical device, implanted by safe and effective, minimally
    invasive surgical techniques, and is safer and more effective as compared to other products.
  • Defendant failed to perform proper and adequate testing and research in order to
    determine and evaluate the risks and benefits of the Product.
  • Feasible and suitable alternatives to the Product have existed at all times relevant that do not present the same frequency or severity of risks as the Product.
  • The Product was at all times utilized and implanted in a manner foreseeable to and in fact intended by the Defendant, its instructions and procedures for use and its training of the health care providers.
  • The Product was implanted in Plaintiff in the same or substantially similar condition as when it left Defendant’s possession.
  • Defendant failed to disclose the known risks and failed to warn of known or scientifically knowable dangers and risks associated with the Product.
  • The Product as designed, manufactured, distributed, sol and/or supplied by Defendant was defective as marketed due to inadequate warnings, labeling and/or inadequate testing.
  • As a result of having the Product implanted, the Plaintiff has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, has suffered financial or economic loss, and/or lost income, and other damages.”  Above allegations are quotes from Julio Nunez complaint)

 

DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO Back to Search Results
Catalog Number 5955460
Event Date 10/10/2014
Event Type  Malfunction
Event Description
The following was reported to a davol: on (b)(6) 2014, during a surgical procedure, using a ventralight st w/ echo an unintended portion of the device was left in the body. The surgeon after fixating the mesh deflated the echo positioning balloon and attempted to pull it from the body, without having cut the inflation tube below the anchor, per the prescribed method. As a result a portion of the inflation tube got caught between the mesh and the abdomen. The surgeon chose to leave that portion of the inflation tube in place behind the mesh. They removed the remaining portion of the inflation assembly and completed the case. Approx. 3-weeks later, the patient required a procedure to repair an intestinal fistula. During the course of the procedure, the previously placed mesh, and portion of the inflation assembly were explanted.
Manufacturer Narrative
The sales representative confirmed that this was the surgeons first use of the echo inflation system. The sales rep had demonstrated the use of the product the day before the case and also just before the case. Unfortunately the surgeon did not follow prescribed removal steps. The method is described in the products instruction-for-use(ifu) provided with the device. As the surgeon failed to cut the inflation tube below the portion of the anchor tube that engages the inflator, the anchor was pulled behind the mesh where it became stuck. As was reported the fistula formation and need for surgical intervention appear to be unrelated to the problem that occurred during the implant procedure. This mdr includes all patient, event and device information davol has received to date. If additional information is obtained, a follow up mdr will be submitted.
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Brand Name VENTRALIGHT ST W/ECHO
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
Warwick RI
Manufacturer (Section G)
DAVOL INC., SUB. C.R. BARD, INC.
San Geronimo Industrial Park
Lot#1, Road#3, Km 79.7
Humacao 0079 1
Manufacturer Contact
Laura Berg
100 Sockanossett Crossroad
Warwick , RI 02886
8005566756
MDR Report Key 4250243
Report Number 1213643-2014-00403
Device Sequence Number 1
Product Code FTL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received 11/06/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number 5955460
Device LOT Number HUYD1243
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received 10/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured 04/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial