FDA Adverse Event
Injury
Summary report: N
KUGEL PATCH
MDR report key: 1802577
·
Received August 11, 2010
Report
- Report Number
- 1213643-2010-00373
- Event Type
- Injury
- Date Received
- August 11, 2010
- Report Date
- July 21, 2010
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K963141
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL; PT'S EVENT AND DEVICE'S INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
ATTORNEY REPORTED: PT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF DEFECTIVE PRODUCT, BARD KUGEL MESH. SPECIFICALLY, AS A RESULT OF HAVING THE KUGEL MESH PATCH IMPLANTED IN PT, PT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KUGEL PATCH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |