FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7 CM 1.0MM
MDR report key: 3170527
·
Received June 12, 2013
Report
- Report Number
- 9617613-2013-00326
- Event Type
- Injury
- Date Received
- June 12, 2013
- Date of Event
- January 21, 2002
- Report Date
- May 20, 2013
- 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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. GYNECARE TVT AND IN-FAST WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264890 | PELVICOL 2CM X 7 CM 1.0MM | NONE | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |