FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX...
MDR report key: 2840380
·
Received September 7, 2012
Report
- Report Number
- 9617613-2012-00165
- Event Type
- Injury
- Date Received
- September 7, 2012
- Report Date
- May 29, 2018
- Manufacturer
- COVIDIENT, 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: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADDITIONAL INFO FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL ACELLULAR COLLAGEN MATRIX... | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE... | NA | 07B08-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention| O |