FDA Adverse Event
Injury
Summary report: N
MESH - COMPOSIX KUGEL
MDR report key: 829843
·
Received March 16, 2007
Report
- Report Number
- 1213643-2007-00081
- Event Type
- Injury
- Date Received
- March 16, 2007
- Date of Event
- October 30, 2003
- Report Date
- March 16, 2007
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETURNED FOR EVAL. THEREFORE, NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
ATTORNEY'S ALLEGATIONS, THAT PT WAS IMPLANTED IN 2003 WITH COMPOSIX KUGEL MESH AND HAS "SUSTAINED AND WILL CONTINUE TO SUSTAIN, INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, MEDICAL MONITORING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH - COMPOSIX KUGEL | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |