MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X SURGICAL MESH

Catalog Number 0123810

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Unspecified Infection (1930); Bowel Perforation (2668)

Event Date 08/16/2017

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 perforation, disability, infection, and subsequent surgical intervention for mesh explant. The instructions-for-use (ifu) supplied with the device lists adhesions as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " this emdr represents the bard/davol composix mesh e/x (device #2). An additional emdr was submitted to represent the bard/davol composix mesh e/x (device #1). Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Attorney alleges that on or about (b)(6) 2004, the patient underwent surgery for repair of an incarcerated umbilical and epigastric hernia and a bard/davol composix e/x mesh was implanted to repair the hernia defect. It is alleged that on or about (b)(6) 2005, the patient underwent an additional surgery due to a hernia recurrence and a bard/davol composix e/x mesh was implanted to repair the hernia defect. It is alleged that the patient underwent an additional surgery on or about (b)(6) 2017 due to necrotizing infection of the anterior abdominal wall from a small bowel eroding into the mesh and perforating into the abdominal wall. Removal of the infected mesh, bowel resection, debridement of anterior wall, lysis of adhesions and repair of small bowel perforation was performed. It is alleged that on or about (b)(6) 2017, the patient underwent an additional surgery due to necrotizing infection of the anterior abdominal wall with involvement of the small bowel. A wound vac was placed to help with treatment. Attorney also alleges that the patient underwent additional surgeries on or about (b)(6) 2017 during which debridement of abdominal wall wound and vacuum-assisted closure device change was performed. On or about (b)(6) 2017, the patient underwent removal of the wound vac, debridement and irrigation of anterior abdominal wall and reapplication of abdominal wound vac. Attorney alleges that the patient's pain, disability, hospitalizations, and additional surgeries were caused solely as a result of the negligence of the defendants. It is alleged that the patient has suffered and continues to suffer from chronic pain, has undergone and will likely require in the further other forms of care and medical treatment. It is also alleged that the device was defective.

• Brand Name: COMPOSIX MESH E/X
• 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: 12627987
• MDR Text Key: 276490754
• Report Number: 1213643-2021-08165
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/28/2009
• Device Catalogue Number: 0123810
• Device Lot Number: 43FOD268
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/13/2021 Patient Sequence Number: 1