FDA Adverse Event
Injury
Summary report: N
PELVICOL 4 X 12 CM
MDR report key: 3232228
·
Received July 8, 2013
Report
- Report Number
- 9617613-2013-00475
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- December 3, 2009
- Report Date
- June 12, 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
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
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. GYNECARE TVT WAS REPORTED TO BE USED/ IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310285 | PELVICOL 4 X 12 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 06B08-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | PELVICOL 4 X 12 CM: 482412, LOT #: 07B03-08| PELVICOL 4 X 12 CM: 482412, LOT #: 07B03-08 |