FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
MDR report key: 3192481
·
Received May 15, 2013
Report
- Report Number
- 9617613-2013-00244
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- December 8, 2004
- Report Date
- May 7, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE RPTR: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. GYNECARE TVT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216264 | PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 03B16-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | LOT #: 03B17-2 4X7CM| PELVICOL ACELLULAR COLLAGEN MATRIX, 482047,| PELVICOL ACELLULAR COLLAGEN MATRIX, 482047,| LOT #: 03B17-2 4X7CM |