FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP TRANSOBTUR KIT X1
MDR report key: 2903099
·
Received November 13, 2012
Report
- Report Number
- 9615742-2012-00588
- Event Type
- Injury
- Date Received
- November 13, 2012
- Report Date
- October 19, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- 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
(B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR A "URETEX". ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: URETEX TO URETHRAL SUPPORT SYSTEM, CATALOG #UNKNOWN, (B)(6). ATTORNEY.
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, PERMANENT INJURY AND PHYSICAL DEFORMITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP TRANSOBTUR KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other| R |