FDA Adverse Event
Injury
Summary report: N
PELVICOL 6X8 CM
MDR report key: 2901280
·
Received November 16, 2012
Report
- Report Number
- 9617613-2012-00252
- Event Type
- Injury
- Date Received
- November 16, 2012
- Report Date
- May 21, 2018
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- 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). ADD'L INFO FROM IMPORTER REPORT: (B)(6) 2012, PELVICOL ACELLULAR COLLAGEN MATRIX. (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L INFO FROM IMPORTER REPORT: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL 6X8 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC | NA | 05B16-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention| O | GYNECARE TVT SECUR| GYNECARE TVT SECUR| GYNECARE TVT SECUR| GYNECARE TVT SECUR |