FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3202340
·
Received June 21, 2013
Report
- Report Number
- 9615742-2013-00538
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- August 15, 2005
- Report Date
- May 28, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282619 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION | SFDCC244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |