FDA Adverse Event
Injury
Summary report: N
UNK PELVICOL PRODUCT
MDR report key: 2963206
·
Received February 4, 2013
Report
- Report Number
- 9617613-2013-00025
- Event Type
- Injury
- Date Received
- February 4, 2013
- Date of Event
- August 3, 2009
- Report Date
- June 21, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSU
- 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: 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 SEVERE PAINFUL AND PERMANENT INJURIES, DISABILITY AND IMPAIRMENT. ADD'L INFO FROM THE IMPORTER REPORT: ASSOCIATED MDR: 1018233-2013-00263.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46512 | UNK PELVICOL PRODUCT | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSU | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R |