MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH VENTRALEX; SURGICAL MESH

Catalog Number 0010301

Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including bowel obstruction, adhesions, abscess and subsequent surgical intervention for mesh explant.The instructions-for-use supplied with the device lists adhesions and infections as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the patch.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.

Event Description

Attorney alleges that on or about (b)(6) 2011, the patient underwent surgery for repair of an incisional hernia and a bard/davol ventralex hernia patch was implanted.It is alleged that the patient underwent an additional surgery to remove the ventralex mesh on or about (b)(6) 2019.The surgeon noted that a loop of small bowel was densely adherent to the mesh and the bowel was fused to the mesh in three (3) locations.It is also alleged that as a result, the mesh was "balled" up and required extensive adhesiolysis.Attorney alleges that the patient underwent an additional surgery to repair a small bowel obstruction due to dense adhesions on or about (b)(6) 2019.The surgeon performed a laparotomy and segmental small bowel resection and open lysis of adhesions for greater than three (3) hours.It also alleged that the patient underwent an additional surgery to treat a post-operative wound infection, which included drainage and debridement of an abdominal wall abscess, and removal of additional hernia mesh on or about (b)(6) 2019.It is alleged that the patient was injured severely and permanently.Attorney alleges that the patient has been injured, suffered and will continue to suffer physical pain, disability, impairment and requires further medical treatment, including likely need for future surgeries.It is also alleged that the device was defective.

• Brand Name: MESH VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 12445513
• MDR Text Key: 270485102
• Report Number: 1213643-2021-07488
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 0010301
• Device Lot Number: HUVD0963
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability