FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX
MDR report key: 3142365
·
Received May 17, 2013
Report
- Report Number
- 1018233-2013-02099
- Event Type
- Injury
- Date Received
- May 17, 2013
- Report Date
- April 19, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTM
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220045 | PELVICOL ACELLULAR COLLAGEN MATRIX | FTM | TISSUE SCIENCE LABORATORIES | NA | 04B08-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |