FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 2913630
·
Received November 21, 2012
Report
- Report Number
- 9615742-2012-00594
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 25, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K012949
- 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. ADD'L INFO FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR NUMBER: 1018233-2012-01775.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | D24331SUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R | PELVISOFT ACELLULAR COLLAGEN BIOMESH |