FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 2840333
·
Received October 19, 2012
Report
- Report Number
- 9617613-2012-00231
- Event Type
- Injury
- Date Received
- October 19, 2012
- Report Date
- September 21, 2012
- Manufacturer
- COVIDIENT, FORMERLY TISSUE
- Product Code
- FTL
- 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: 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. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PATIENT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE | NA | 03B01B520180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other| R |