FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MARTRIX
MDR report key: 3019263
·
Received March 18, 2013
Report
- Report Number
- 9617613-2013-00097
- Event Type
- Injury
- Date Received
- March 18, 2013
- Date of Event
- July 19, 2001
- Report Date
- April 9, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE DEVICE WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112319 | PELVICOL ACELLULAR COLLIGEN MARTRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC | 01A05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Other |