FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 3111718
·
Received April 16, 2013
Report
- Report Number
- 9617613-2013-00150
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- August 18, 2003
- Report Date
- June 17, 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4). .
Description of Event or Problem · 1
PROCEDURE TYPE: 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 PAIN, INJURY, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162386 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |