FDA Adverse Event
Injury
Summary report: N
PELVICOL 6 X 8 CM
MDR report key: 3231678
·
Received July 12, 2013
Report
- Report Number
- 9617613-2013-00497
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- April 24, 2009
- Report Date
- June 17, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE ...
- 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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PRECISION SPEED TAC TRANSVAGINAL ANCHOR SYSTEM WITH USP #1 POLYBUTESTER MONO-FILAMENT NON-ABSORBABLE SUTURE AND BOSTON SCIENTIFIC WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321820 | PELVICOL 6 X 8 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE ... | 07B10-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Other |