FDA Adverse Event
Other
Summary report: N
PROSTATRON
MDR report key: 883697
·
Received July 20, 2007
Report
- Report Number
- 2133936-2007-00017
- Event Type
- Other
- Date Received
- July 20, 2007
- Report Date
- July 19, 2007
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE HAS BEEN RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT 4-5 DAYS AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE PATIENT WAS SENT TO THE HOSPITAL FOR SEVERE BLADDER SPASMS. THE PATIENT HAS BEEN HOSPITALIZED TWICE FOR SEVERE BLADDER SPASMS. A CT SCAN WAS PERFORMED, HOWEVER, NO ABNORMALITY WAS FOUND. PATIENT CURRENTLY HAS A SUPRAPUBIC CATHETER AS HE CANNOT TOLERATE A FOLEY. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. IT IS NOTED THAT MULTIPLE ATTEMPTS TO GATHER FURTHER INFORMATION WAS UNSUCCESSFUL, THEREFORE, NO FURTHER FOLLOW-UP WILL BE ATTEMPTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTATRON | MICROWAVE DELIVERY SYSTEM | MEQ | UROLOGIX, INC. | 220983 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |