FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGED MATRIX
MDR report key: 3152091
·
Received May 29, 2013
Report
- Report Number
- 1018233-2013-02261
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
COMPLAINT# (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233718 | PELVICOL ACELLULAR COLLAGED MATRIX | FTL | TISSUE SCIENCE LABORATORIES | NA | 01A17 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |