FDA Adverse Event
Injury
Summary report: N
PELVOCOL 2CM X 7CM 1.0MM
MDR report key: 3202343
·
Received June 21, 2013
Report
- Report Number
- 9617613-2013-00363
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- January 27, 2004
- Report Date
- May 31, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4)., (IMPORTER).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 282620 | PELVOCOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN | 82A08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |