FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3231653
·
Received July 12, 2013
Report
- Report Number
- 9615742-2013-00785
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- October 11, 2004
- Report Date
- June 18, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- 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
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INJURIES, PAIN, DISABILITY, AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323241 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PELVICOL ACELLULAR COLLAGEN MATRIX| PELVICOL ACELLULAR COLLAGEN MATRIX |