FDA Adverse Event
Injury
Summary report: N
PELVICOL 6 X 8 CM
MDR report key: 3040238
·
Received March 18, 2013
Report
- Report Number
- 9617613-2013-00093
- Event Type
- Injury
- Date Received
- March 18, 2013
- Date of Event
- November 16, 2004
- Report Date
- June 1, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE
- 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
BRAND NAME: PELVICOL ACELLULAR COLLAGEN MATRIX. (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00844.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112309 | PELVICOL 6 X 8 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE | NA | 04B14-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention| O | URETEX SUP URETHRAL SUPPORT SYSTEM| URETEXSUP, URETEX SUPPORT PP KIT X1: (B)(4)| URETEX SUP URETHRAL SUPPORT SYSTEM| URETEXSUP, URETEX SUPPORT PP KIT X1: (B)(4) |