FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX
MDR report key: 3142617
·
Received March 12, 2013
Report
- Report Number
- 1018233-2013-00796
- Event Type
- Injury
- Date Received
- March 12, 2013
- Report Date
- February 14, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
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 |
|---|---|---|---|---|---|---|---|
| 104519 | PELVICOL ACELLULAR COLLAGEN MATRIX | FTL | TISSUE SCIENCE LABORATORIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | AMERICAN MEDICAL SYSTEMS IN-FAST ULTRA -| BOSTON SCIENTIFIC PINNACLE| TRANSVAGINAL SLING |