FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 2941585
·
Received January 17, 2006
Report
- Report Number
- 9615742-2013-00013
- Event Type
- Injury
- Date Received
- January 17, 2006
- Date of Event
- November 30, 2006
- Report Date
- December 12, 2018
- 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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. LIFENET PERIO FASCIA LATA WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | SGI00547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R | LIFENET PERIO FASCIA LATA| LIFENET PERIO FASCIA LATA |