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

Catalog Number 0010205

Device Problems Material Too Rigid or Stiff (1544); Torn Material (3024); Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Date 05/08/2013

Event Type  Injury  

Manufacturer Narrative

Based on the information provided this is a patient with a history of hernia recurrence.At this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged by the patient.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Hernia recurrence is an inherent risk of the procedure and is identified in the ifu as a possible complication.The warning section of the ifu states, "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect." the explanted sample was not returned for evaluation of the alleged condition of the patch upon explant.If additional information is obtained, a follow up mdr will be submitted.This mdr represents the bard/davol composix kugel hernia patch (mesh #2) implanted on (b)(6)2009.A separate mdr was sent to document the bard/davol flat mesh (mesh #1) implanted on (b)(6) 2008, also reference maude event report mw5042923 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.

Event Description

The following was reported to davol via maude event report (mw 5042924): "in 2009 i received bard kugel mesh (0010205) lot husc1806 to repair failed hernia.The mesh was placed in and in 2011 they went in laparoscopically to repair small tear to the side of the mesh.All went well but then it recurred in 2013 and so i went in for abdominal wall repair and hernia repair.When they opened me they found the mesh 0010205 was rock hard so they removed it and other and did not replace with mesh, hoping my tissue would repair from it.Unfortunately i was back in 10 months later for complete repair and mesh placement.Since mesh problems on that side the tissue does not hold well and now, in 2015, am having another occurrence.I'm not sure how these defects were not noted to company that manufactured but now facing a seventh repair." addendum per follow up with the patient: (b)(6) 2008 - implant of the bard/davol flat mesh (mesh# 1) to repair an incisional hernia.(b)(6) 2009 - due to recurrence patient underwent explant of the bard/davol flat mesh (mesh# 1) and implant of the bard/davol composix kugel hernia patch (mesh# 2).(b)(6) 2011- laparoscopic procedure to repair a tear in the bard/davol composix kugel hernia patch with sutures.(b)(6) 2013 - the patient had a new hernia around the patch.Patient underwent hernia repair and abdominal wall reconstructive surgery with explant of the bard/davol composix kugel hernia patch (mesh# 2).It was noted that the bard/davol composix kugel hernia patch (mesh# 2) was "rock hard." the patient reports that the tissue on the right side of her abdomen is not able to hold together and she continues to develop recurrent hernias.

• Brand Name: MESH - COMPOSIX KUGEL
• Type of Device: SUGICAL 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5017989
• MDR Text Key: 23559740
• Report Number: 1213643-2015-00289
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 0010205
• Device Lot Number: HUSC1806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2008
• 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: 29 YR