FDA Adverse Event
Injury
Summary report: N
TARGIS SYSTEM
MDR report key: 1671712
·
Received April 28, 2010
Report
- Report Number
- 2133936-2010-00008
- Event Type
- Injury
- Date Received
- April 28, 2010
- Date of Event
- March 29, 2010
- Report Date
- April 28, 2010
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- PMA / PMN Number
- P970008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DISPOSABLE DEVICES WERE RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE TREATMENT FILE PRINTOUT FROM THE CONTROL UNIT WAS OBTAINED AND REVIEWED ALONG WITH THE CATHETER DEVICE HISTORY RECORD. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES AND THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. THE TREATMENT FILE REVEALED AN UNEVENTFUL, ROUTINE PROCEDURE. AS NO DEVICE WAS RECEIVED FOR ANALYSIS AND THE TREATMENT FILE DEMONSTRATES AN UNEVENTFUL TREATMENT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE PATIENT SUFFERS FROM INCONTINENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGIS SYSTEM | MICROWAVE DELIVERY SYSTEM | MEQ | UROLOGIX, INC. | TA1121D | 091119M1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Disability |