FDA Adverse Event
Injury
Summary report: N
PELVISOFT ACELLULAR COLLAGEN BIOMESH
MDR report key: 3080460
·
Received April 24, 2013
Report
- Report Number
- 1018233-2013-01554
- Event Type
- Injury
- Date Received
- April 24, 2013
- Report Date
- March 25, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTM
- PMA / PMN Number
- K031332
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A MDR SUPPLEMENTAL REPORT WILL BE FILED.
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 REC'D. ASSOCIATED MDR: 1018233-2013-01555.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177558 | PELVISOFT ACELLULAR COLLAGEN BIOMESH | FTM | TISSUE SCIENCE LABORATORIES | NA | 05B17-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | OBTRYX URETHRA SLING| PELVISOFT ACELLULAR COLLAGEN BIOMESH |