FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 3232226
·
Received July 8, 2013
Report
- Report Number
- 9617613-2013-00477
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- January 20, 2003
- Report Date
- June 12, 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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AM8 SCREW WITCH 40CM POLYPROPYLENE SUTURE AND IN-FAST WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309276 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 02A19B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Other |