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

Catalog Number 0010205

Device Problems Defective Device (2588); Folded (2630)

Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)

Event Date 07/11/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.While medical records were provided they were limited to an implant tracking log and explant operative report only.As stated in the medical records this is a patient with a history significant for "multiple abd surgeries." no medical records were provided between the time of implant of the composix kugel mesh and explant of the device, therefore it is unclear if the reported "multiple abd surgeries" may have contributed to the report of significant adhesions.Based on a review of medical records, the patient experienced obstruction and adhesions.Adhesions are listed as a known possible adverse reaction in the instructions-for-use.A manufacturing review was performed and found no anomalies during the manufacturing process.With the current information available no definitive conclusion can be made at this time.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 is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2007 - the patient underwent repair of a ventral hernia with use of a bard composix kugel hernia patch.No operative details were provided for this procedure.On (b)(6) 2015 - the patient was diagnosed with a small bowel obstruction and underwent partial explant of the composix kugel mesh, a small bowel resection and adhesiolysis.Per the operative details the mesh was removed "given the fact the mesh portion that was exposed to the peritoneal cavity." operative findings further indicated the prior composix kugel mesh was folded over with small bowel adherent to the mesh part causing obstruction.Adhesions were significant.

• 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: 6389245
• MDR Text Key: 69437414
• Report Number: 1213643-2017-00162
• 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
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 0010205
• Device Lot Number: 43FQD194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR