FDA Adverse Event
Injury
Summary report: N
PELVICOL 4 X 12 CM
MDR report key: 3231647
·
Received July 12, 2013
Report
- Report Number
- 9617613-2013-00516
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- February 21, 2005
- Report Date
- February 6, 2018
- 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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER). (B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323178 | PELVICOL 4 X 12 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 04B05-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Other |