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

Catalog Number 0134810

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

With the current information provided, no conclusion can be made.It is alleged the patient experienced infection and adhesions.Adhesions is a known inherent risk of hernia repair surgery and are identified in the adverse reactions section of the ifu as a known possible complication.In regards to infection, the warning section of the ifu 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.¿ with no lot number provided a review of the manufacturing records could not be conducted.This file represents one of the two (2) composix lp devices, a second file was created to address the second composix lp device.No device returned for evaluation.

Event Description

As reported, on (b)(6) 2007, the patient underwent surgery for implant of two (2) bard/davol composix l/p mesh.It was reported that the patient began to experience abdominal pain toward the end of 2018 and underwent additional surgery on (b)(6) 2019 for partial explant of both devices.It is alleged that the mesh had caused a staph infection and lysis of adhesions from her appendix and intestines.

• Brand Name: COMPOSIX LP
• 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: 9694868
• MDR Text Key: 193037388
• Report Number: 1213643-2020-01100
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0134810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• 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