FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3220944
·
Received July 3, 2013
Report
- Report Number
- 9615742-2013-00702
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- May 22, 2006
- Report Date
- June 10, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY. PELVISOFT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306599 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION | SGA00717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other | PARIETEX UGYTEX PP 15X10CM X1: UGY1510,| LOT # P24343G3, EXP: 12/31/2009, MFR: 12/2004 |