FDA Adverse Event
Injury
Summary report: N
PELVILACE BIOURETHRAL SUPPORT SYSTEM
MDR report key: 3022506
·
Received March 20, 2013
Report
- Report Number
- 1018233-2013-00929
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- February 25, 2013
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- PMA / PMN Number
- K031295
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).
Description of Event or Problem · 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDIITONAL HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00928.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116970 | PELVILACE BIOURETHRAL SUPPORT SYSTEM | FTL | TISSUE SCIENCE LABORATORIES | NA | 03JO2016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |