FDA Adverse Event
Injury
Summary report: N
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
MDR report key: 3454325
·
Received November 1, 2013
Report
- Report Number
- 1018233-2013-09012
- Event Type
- Injury
- Date Received
- November 1, 2013
- Report Date
- October 3, 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
- PA, 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).
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
IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562033 | PELVILACE TO BIOURETHRAL SUPPORT SYSTEM | FTL | TISSUE SCIENCE LABORATORIES | NA | BMUF0014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PELVISOFT ACELLULAR COLLAGEN BIOMESH |