FDA Adverse Event
Injury
Summary report: N
PELVICOL PRODUCT
MDR report key: 2840345
·
Received September 13, 2012
Report
- Report Number
- 9617613-2012-00180
- Event Type
- Injury
- Date Received
- September 13, 2012
- Report Date
- August 14, 2012
- 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR AN "UNK PELVICOL". ADDITIONAL INFO FROM IMPORTER REPORT: (B)(4) 2012. PELVICOL ACELLULAR COLLAGEN MATRIX. (B)(4). (B)(6).
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 PRODUCT | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE... | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |