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

Catalog Number UNKAA015

Device Problem Defective Device (2588)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. It is alleged the patient experienced adhesions and infection. Adhesions are listed as a 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. ¿ without a lot number a review of the manufacturing records could not be conducted. With the currently available information, no conclusion can be drawn. 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. Device not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent implant of a composix e/x mesh to treat a recurrent incisional hernia. On (b)(6) 2015 - the patient was allegedly diagnosed with "infected mesh" and required a subsequent surgery to remove the composix e/x. The surgeon excising the mesh alleged that the patient had "multiple adhesions to his abdominal wall," and performed lysis of adhesions allegedly caused by the composix e/x mesh. The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant.

• Brand Name: COMPOSIX 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6510854
• MDR Text Key: 73350087
• Report Number: 1213643-2017-00264
• 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: 04/21/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/21/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNKAA015
• 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: 03/29/2017
• 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: 04/21/2017 Patient Sequence Number: 1