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

Catalog Number UNKAA016

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

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.Medical records have not been provided.Without a lot number a review of the manufacturing records could not be conducted.Additionally, no product was returned for evaluation.It is alleged the patient experienced adhesions.Adhesions is listed as a known possible adverse reaction in the instructions-for-use.With the currently available information, no conclusion can be drawn.Attorney alleges that the device was a recalled device, however did not provide product identifiers.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.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2005 - the patient underwent a ventral incisional hernia repair with implant of a bard/davol composix kugel hernia patch.At some point post procedure, the patient allegedly began experiencing abdominal pain which was alleged to be the result of the composix kugel mesh folding over on itself and adhering to the patient's small bowel.This required alleged surgical removal of the composix kugel.The attorney alleges the patient suffered "pain and suffering," abdominal pain, adhesions, folded mesh and explant.

• 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: 5128608
• MDR Text Key: 27520236
• Report Number: 1213643-2015-00338
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• 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