FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MATRIX
MDR report key: 3093912
·
Received April 24, 2013
Report
- Report Number
- 9617613-2013-00184
- Event Type
- Injury
- Date Received
- April 24, 2013
- Date of Event
- December 8, 2004
- Report Date
- June 22, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AMS IN-FAST ULTRA WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176439 | PELVICOL ACELLULAR COLLIGEN MATRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES | 04B14-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |