FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MATRIX
MDR report key: 2901277
·
Received December 10, 2012
Report
- Report Number
- 9617613-2012-00273
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- April 24, 2011
- Report Date
- November 14, 2012
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADD'L INFO FROM IMPORTER REPORT: (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL ACELLULAR COLLIGEN MATRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC | NA | 10B18-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Other |