FDA Adverse Event
Injury
Summary report: N
PELVICOL 4 X 12 CM
MDR report key: 3252289
·
Received July 22, 2013
Report
- Report Number
- 9617613-2013-00579
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- February 5, 2004
- Report Date
- July 1, 2013
- 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 REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339736 | PELVICOL 4 X 12 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 03B15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | PELVICOL ACELLULAR COLLAGEN MATRIX, | PROD # 482412, LOT # 03B15| PELVICOL ACELLULAR COLLAGEN MATRIX,| PROD # 482412, LOT # 03B15 |