FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 3131020
·
Received May 9, 2013
Report
- Report Number
- 9617613-2013-00224
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 5, 2004
- Report Date
- June 22, 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
- Health Professional
- N
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 PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204874 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 03B10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Other |