FDA Adverse Event
Malfunction
Summary report: N
TARGIS SYSTEM
MDR report key: 3901948
·
Received June 30, 2014
Report
- Report Number
- 2133936-2014-00003
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 30, 2014
- Report Date
- June 27, 2014
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- PMA / PMN Number
- P970008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVALUATION SHOWED THAT THE LOCATION BALLOON HAD A SMALL LEAK DUE TO EITHER AN INCOMPLETE FILL, VOID, OR AIR BUBBLES IN THE ADHESIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SMALL LEAK WAS DISCOVERED AT THE BOTTOM OF THE COUDE TIP. THE TREATMENT WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379985 | TARGIS SYSTEM | MICROWAVE DELIVERY SYSTEM FOR BPH. | MEQ | UROLOGIX, INC. | 410097-001 | 130926MCA1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |