FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX
MDR report key: 3131393
·
Received May 13, 2013
Report
- Report Number
- 9617613-2013-00265
- Event Type
- Injury
- Date Received
- May 13, 2013
- Date of Event
- April 15, 2004
- Report Date
- April 17, 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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'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 |
|---|---|---|---|---|---|---|---|
| 211725 | PELVICOL ACELLULAR COLLAGEN MATRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 03B18-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |