MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX

Catalog Number UNKAA018

Device Problem Folded (2630)

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Date 05/12/2011

Event Type  Injury  

Event Description

The following is based off a review of the patient's medical records provided to davol by the patient's attorney: on (b)(6) 2005- the patient underwent a bilateral hernia repair with implant of two unspecified mesh implants.The patient also underwent primary repair (no implant) of an umbilical hernia during this procedure.At sometime following the (b)(6) 2005 procedure it appears that the patient was implanted with a bard/davol composix mesh.No operative report was provided.On (b)(6) 2011 - patient underwent a revision procedure.A large piece of what appeared to be composix dual mesh was fixed to the anterior abdominal wall at the umbilical location.Medical records indicate the composix mesh had folded back on itself so that the mesh part was exposed to the omentum and to several pieces of small bowel.The patient underwent laparoscopic lysis of adhesions, and laparoscopic peri-umbilical hernia repair.A non-bard/non-davol mesh was super imposed over the composix mesh and it remains implanted.

Manufacturer Narrative

As reported the mesh was found to be folded over at the site.The medical records indicate the patient was treated for adhesions and for hernia repair.Adhesions and recurrence are listed as a known possible adverse reaction in the instructions for use (ifu) supplied with the device.Without a lot number a review of the manufacturing records could not be conducted.At this time no conclusions can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.

• Brand Name: MESH - COMPOSIX
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4193821
• MDR Text Key: 5154444
• Report Number: 1213643-2014-00361
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

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 Catalogue Number: UNKAA018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 41 YR
• Patient Weight: 99