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)

Patient Problems Pain (1994); Disability (2371); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided alleges the patient experienced a ring break. Without the sample being returned for evaluation, the allegation of a ring break can not be assessed and the possible reason for the break could not be determined. With the current information available, no definitive conclusion can be made. 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) 2006 - the patient underwent a hernia repair with implant of a composix kugel mesh device. It is alleged the recoil ring in the composix kugel product subsequently broke and caused the device to flip over and perforate patient's bowel. The patient required substantial additional medical procedures and care to remove the defective composix kugel product, repair her bowel and to treat other resulting complications. The attorney alleges the patient experienced pain, additional surgical procedure, ring break, bowel perforation and was seriously and permanently injured.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 7007438
• MDR Text Key: 91290359
• Report Number: 1213643-2017-00804
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2011
• Device Catalogue Number: 0010206
• Device Lot Number: 43DQD802
• 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: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2006
• 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: 11/07/2017 Patient Sequence Number: 1