FDA Adverse Event
Injury
Summary report: N
TARGIS SYSTEM
MDR report key: 2822419
·
Received June 25, 2012
Report
- Report Number
- 2133936-2012-00005
- Event Type
- Injury
- Date Received
- June 25, 2012
- Date of Event
- May 21, 2012
- Report Date
- June 21, 2012
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- PMA / PMN Number
- P970008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR REMARKED THAT THE PT PROSTATE WAS VERY LARGE AND SO HE USED THE LARGEST CTC ADVANCE CATHETER AVAILABLE. THE DISPOSABLE DEVICE WAS NOT RETURNED. A DISK WITH THE TREATMENT FILE FROM THE CONTROL UNIT WAS SENT BACK, BUT DISK WAS BLANK. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH THE STANDARD PROCEDURES AND THE DISPOSABLE UNIT MET ITS SPECS AT THE TIME OF RELEASE.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED EXTREME PAIN AT 15 MINUTES THEN THE PROCEDURE WAS ENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGIS SYSTEM | MICROWAVE DELIVERY SYSTEM | MEQ | UROLOGIX, INC. | 120405MLA1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other | LIDOCAINE JELLY| MORPHINE SHOTS |