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

Catalog Number 0010206

Device Problems Break (1069); Defective Device (2588); Folded (2630); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)

Event Date 05/15/2015

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 it was alleged the patient experienced adhesions of mesh, alleged folded mesh and ring break. Adhesions are listed as a known possible adverse reaction in the instructions-for-use. In regards to the allegation of ring break, the device was not returned for evaluation therefore the allegation of ring break can not be confirmed and the reason for the ring break can not be determined. The patient's medical history between the date of implant in (b)(6) 2004 and the date of explant in 2015 is unknown at this time. 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. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent implant of the bard composix kugel mesh patch to treat a ventral hernia. On (b)(6) 2015 - the patient was admitted to the hospital for emergency surgery to remove the composix kugel mesh patch and repair a recurrent incarcerated ventral hernia. The surgeon removing the mesh patch noted " a lot of adhesions stuck to the mesh" and subsequently performed extensive lysis of the adhesions. The surgeon also noted that there were points where the mesh had "curled up onto itself and folded backwards causing the bowel to be stuck to the polypropylene part of the mesh. " the surgeon identified the composix kugel mesh patch as the source of the patient's bowel injuries and determined that there was no way to unfold the mesh. Upon inspection of the mesh, the surgeon found that "the polyester ring holding the mesh flat had broken in multiple places. " the attorney alleges the patient has experienced significant mental and physical pain and suffering, sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, recurrence, adhesions and curled/folded mesh.

• Brand Name: MESH - COMPOSIX KUGEL
• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 6519560
• MDR Text Key: 73620922
• Report Number: 1213643-2017-00272
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/28/2008
• Device Catalogue Number: 0010206
• Device Lot Number: 43END417
• 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: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0524-06

Patient Treatment Data

Date Received: 04/25/2017 Patient Sequence Number: 1