FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 2895255
·
Received November 30, 2012
Report
- Report Number
- 9615742-2012-00600
- Event Type
- Injury
- Date Received
- November 30, 2012
- Date of Event
- May 28, 2008
- Report Date
- November 1, 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 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: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, AND HAS UNDERGONE CORRECTIVE SURGERIES. ASSOCIATED MDR# 1018233-2012-00391.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | SGK00088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other| R | URETEX SUP URETHRAL SUPPORT SYSTEM |