FDA Adverse Event
Injury
Summary report: N
PELVISOFT ACELLULAR COLLAGEN BIOMESH
MDR report key: 3213812
·
Received July 3, 2013
Report
- Report Number
- 1018233-2013-02731
- Event Type
- Injury
- Date Received
- July 3, 2013
- Report Date
- June 6, 2013
- Manufacturer
- TISSUE SCIENCE LABS
- Product Code
- FTM
- PMA / PMN Number
- K031332
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP SUPPLEMENTAL REPORT WILL BE MAILED.
Description of Event or Problem · 1
(B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR NUMBER: 1018233-2013-02736.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303556 | PELVISOFT ACELLULAR COLLAGEN BIOMESH | FTM | TISSUE SCIENCE LABS | NA | 05B13-8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | PELVISOFT ACELLULAR COLLAGEN BIOMESH| PROD # 481068, LOT 04B32-1 |