FDA Adverse Event
Injury
Summary report: N
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
MDR report key: 3345476
·
Received September 5, 2013
Report
- Report Number
- 1018233-2013-07060
- Event Type
- Injury
- Date Received
- September 5, 2013
- Report Date
- August 7, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- PMA / PMN Number
- K042949
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: (B)(4).
Description of Event or Problem · 1
(B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THIS DEVICE. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441381 | PELVILACE TO BIOURETHRAL SUPPORT SYSTEM | FTL | TISSUE SCIENCE LABORATORIES | NA | CVQH0005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | REF# (B)(4) - LOT# ZGE00581| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM - |