FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 2120446
·
Received June 3, 2011
Report
- Report Number
- 9615742-2011-00048
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- August 20, 2008
- Report Date
- December 22, 2015
- 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
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: GYNECOLOGICAL/UROLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT SURGERY FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE WHICH INCLUDED REPAIR FOR STRESS URINARY INCONTINENCE AND CYSTOCELE. THE PATIENT ALLEGEDLY EXPERIENCED PAIN, INJURY, BLEEDING, AND INFECTIONS. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | SIA00378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention| O |