FDA Adverse Event
Injury
Summary report: N
PELVICOL 2 X 4 CM
MDR report key: 3170518
·
Received June 12, 2013
Report
- Report Number
- 9617613-2013-00330
- Event Type
- Injury
- Date Received
- June 12, 2013
- Date of Event
- May 23, 2003
- 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
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER). (B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: STRESS URINARY INCONTINENCE. 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 |
|---|---|---|---|---|---|---|---|
| 264889 | PELVICOL 2 X 4 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Other |