FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 3143141
·
Received May 24, 2013
Report
- Report Number
- 9617613-2013-00292
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- March 29, 2005
- Report Date
- May 1, 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, SUFFERING, DISABILITY AND IMPAIRMENT. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231067 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 04005-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |