FDA Adverse Event
Injury
Summary report: N
PELVISOFT ACELLULAR COLLAGEN BIOMESH
MDR report key: 3378187
·
Received September 25, 2013
Report
- Report Number
- 1018233-2013-07608
- Event Type
- Injury
- Date Received
- September 25, 2013
- Report Date
- October 12, 2015
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- 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 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
1994 = "L".
Description of Event or Problem · 1
(B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWL PROBLEMS, DYSPAREUNIA, VAGINAL STRICTURE, NON-SURGICAL INTERVENTIONS AND ADDITIONAL SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483938 | PELVISOFT ACELLULAR COLLAGEN BIOMESH | FTM | TISSUE SCIENCE LABORATORIES | NA | 08B02-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |