FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX
MDR report key: 3152248
·
Received March 5, 2013
Report
- Report Number
- 9617613-2013-00075
- Event Type
- Injury
- Date Received
- March 5, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IMP REF #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94889 | PELVICOL ACELLULAR COLLAGEN MATRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 04B14-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |