MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. KUGEL PATCH

Catalog Number UNKAA043

Device Problem Folded (2630)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The following allegation was reported to davol by the pt.The pt has alleged that she was implanted with a kugel patch in 2003 and has been in severe off and on pain since 2005.She alleges that she has undergone additional surgery and another manufacturer's graft was placed over the kugel patch.The pt alleges that she continues to seek treatment from a physician and pain clinic to manage pain.Pt states her previous ct scan revealed that the implanted patch is "folded over" in the lower left quadrant.

Manufacturer Narrative

We have requested that the pt provide us with additional info including: product identifiers and specific dates of her procedures.She has stated that she does not have product identifiers.Without product identifiers a review of the manufacturing records cannot be conducted.Based on the limited info provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.This mdr includes all pt, event and device info davol has received to date.If additional info is obtained, a follow up mdr will be submitted.

• Brand Name: KUGEL PATCH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd; warwick, RI 02886 ; 8005566786
• MDR Report Key: 4665065
• MDR Text Key: 15233098
• Report Number: 1213643-2015-00102
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 03/09/2015

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: UNKAA043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/01/2015
• 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