FDA Adverse Event
Injury
Summary report: N
PELVICOL 6 X 8 CM
MDR report key: 3244805
·
Received February 14, 2013
Report
- Report Number
- 9617613-2013-00037
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- September 22, 2008
- Report Date
- November 1, 2017
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PLEASE REFER IMPORTER REPORT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66352 | PELVICOL 6 X 8 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC | 07B03-7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female |