FDA Adverse Event
Injury
Summary report: N
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
MDR report key: 3315375
·
Received August 23, 2013
Report
- Report Number
- 1018233-2013-06790
- Event Type
- Injury
- Date Received
- August 23, 2013
- Report Date
- July 24, 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
- 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.
Description of Event or Problem · 1
(B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413414 | PELVILACE TO BIOURETHRAL SUPPORT SYSTEM | FTL | TISSUE SCIENCE LABORATORIES | NA | CVPK0018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |