FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP TRANSOBTUR KIT X1
MDR report key: 3231931
·
Received July 11, 2013
Report
- Report Number
- 9615742-2013-00743
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- December 14, 2004
- Report Date
- June 13, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K041176
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Description of Event or Problem · 1
PROCEDURE TYPE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: PT REPORTS EXPERIENCING PAIN AND INFECTION. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVISOFT ACELLULAR COLLAGEN BIOMESH WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319765 | URETEX SUPPORT PP TRANSOBTUR KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |