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

Model Number 0123810

Device Problem Defective Device (2588)

Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371)

Event Date 12/06/2013

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided, the patient experienced adhesions, adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. Based on the information provided, there is an error with the dates provided in the sequence of events. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent surgery for repair of a ventral hernia. A composix e/x hernia patch, (b)(4) and lot number 43hpd666 was implanted to repair the hernia defect. (b)(6) 2013 - the patient underwent an additional surgery to release adhesions between patient's bowel and the composix e/x mesh and to remove the implanted mesh. (b)(6) 2013 - the patient had a subsequent surgery to again remove the composix e/x mesh. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

• 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: 7155016
• MDR Text Key: 96057890
• Report Number: 1213643-2017-01141
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 0123810
• Device Catalogue Number: 0123810
• Device Lot Number: 43HPD666
• 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: 12/08/2017
• 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 Treatment Data

Date Received: 12/29/2017 Patient Sequence Number: 1