FDA Adverse Event
Injury
Summary report: N
URETEX SUP URETHRAL SUPPORT SYSTEM
MDR report key: 3172311
·
Received April 24, 2013
Report
- Report Number
- 1018233-2013-01537
- Event Type
- Injury
- Date Received
- April 24, 2013
- Report Date
- September 26, 2018
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- OTN
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177929 | URETEX SUP URETHRAL SUPPORT SYSTEM | No Match | OTN | C.R. BARD, INC. (COVINGTON) -1018233 | NA | C24146SUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | MARLEX MESH |