FDA Adverse Event
Injury
Summary report: N
PELVICOL 4 X 12 CM
MDR report key: 3111723
·
Received April 10, 2013
Report
- Report Number
- 9617613-2013-00146
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- March 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
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 |
|---|---|---|---|---|---|---|---|
| 154078 | PELVICOL 4 X 12 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 02A21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PELVICOL 4 X12 CM: 482412, LOT # 02A30| PELVICOL 6 X 8 CM: 482068, LOT # 02A22 |