FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
MDR report key: 3202338
·
Received June 21, 2013
Report
- Report Number
- 9617613-2013-00341
- Event Type
- Injury
- Date Received
- June 21, 2013
- Report Date
- May 28, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE
- 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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4)., (IMPORTER).
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 |
|---|---|---|---|---|---|---|---|
| 283351 | PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE | 04B15-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |