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

Catalog Number 0123460

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Date 03/17/2011

Event Type  Injury  

Manufacturer Narrative

Based on a review of medical records, the patient experienced infection, pain, adhesions, fistula formation and obstruction. Adhesions and fistula formation are listed as known possible adverse reaction in the instructions-for-use. In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ a manufacturing review was performed which found no anomalies during the manufacturing process. With the information currently provided, it is unknown if the patient's bard davol mesh may have caused or contributed to the patient's reported events, due to the patient's surgical history of abdominal surgeries prior to implant of the bard mesh and the unknown medical history between implant of the bard mesh in 2006 and the md evaluation in 2011. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2006 - the patient was diagnosed with an incarcerated ventral hernia and underwent repair with implant of a davol composix e/x mesh followed by implant of a ventralex hernia patch placed "at the trocar site. " no operative details provided for this procedure. On (b)(6) 2011 - the patient presented for evaluation of a non healing sore on his abdominal wall that has been present for the last few months. Per the md exam notes, no recurrent ventral hernia. On the right mid abd there is a punctuate opening with surrounding granulation. This appears to be a cutaneous fistula. No obvious stool discharge from this fistula tract, however, concern for enterocutaneous fistula. On (b)(6) 2011 - the patient presented to the er with complaints of nausea, vomiting and abdominal pain. A ct scan of the abd and pelvis were performed with findings of a small bowel obstruction with a transition zone in the mid abdomen. The patient had previously been worked up the past few weeks for an enterocutaneous fistula in a right paramedian location. A nasogastric tube was placed in the er. On (b)(6) 2011 - the patient underwent an exploratory laparotomy with excision of infected abdominal wall mesh. Per operative details, "a prolonged, extremely difficult dissection was performed to mobilize the anterior abd wall from infected mesh and densely adherent small intestine and omentum. " the details also stated that the central portion of the jejunum which was obstructed and densely adherent to the mesh with the enterocutaneous fistula was resected en bloc. " operative findings noted small bowel eroded into the mesh with abscess formation and also enterocutaneous fistula formation. High grade small bowel obstruction as well.

• Brand Name: COMPOSIX EX
• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6398871
• MDR Text Key: 69793676
• Report Number: 1213643-2017-00172
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,OTHER
• Reporter Occupation: ATTORNEY
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/13/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/31/2010
• Device Catalogue Number: 0123460
• Device LOT Number: 43JPD516
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/19/2005
• 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: 03/13/2017 Patient Sequence Number: 1