FDA Adverse Event
Injury
Summary report: N
PELVICOL (BARD) 8CM X 12CM
MDR report key: 3131338
·
Received May 17, 2013
Report
- Report Number
- 9617613-2013-00262
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- March 10, 2009
- Report Date
- April 23, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE
- 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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220360 | PELVICOL (BARD) 8CM X 12CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE | 06B07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |