FDA Adverse Event
Injury
Summary report: N
MESH - COMPOSIX KUGEL
MDR report key: 1973875
·
Received January 19, 2011
Report
- Report Number
- 1213643-2011-00022
- Event Type
- Injury
- Date Received
- January 19, 2011
- Report Date
- December 30, 2010
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K003323
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
ATTORNEY REPORTED: ON (B)(6) 2004: PT HAD A COMPOSIX KUGEL MESH IMPLANTED TO REPAIR A HERNIA DEFECT. AFTER SUFFERING SEVERE INJURIES ASSOCIATES WITH THE DEFECTIVE NATURE OF THIS PRODUCT, THE PT'S KUGEL PATCH WAS REMOVED. PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH - COMPOSIX KUGEL | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |