FDA Adverse Event
Injury
Summary report: N
PELVICOL 4 X 12 CM
MDR report key: 3231649
·
Received July 12, 2013
Report
- Report Number
- 9617613-2013-00509
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 26, 2007
- Report Date
- June 21, 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
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
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. PELVILACE TO BIOURETHRAL SUPPORT SYSTEM AND BARD MESH PERFIX PLUG WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324175 | PELVICOL 4 X 12 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 06B04-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Other |