N
Patient 1
THE HIFU DEVICE, SONOBLATE-500 IS UNDER IDE STUDY. THE ADVERSE EVENT IS AN ANTICIPATED EVENT. THE IDE STUDY # (B)(4) IS NOW CLOSED ENROLLING PTS AS IT HAS COMPLETED ALLOWABLE NUMBER FOR THE STUDY.
MAUDE MDR 5095445
- MDR report key
- 5095445
- Report number
- 2951226-2004-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-08-21
- Date received
- 2004-09-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NARENDRA SANGHVI
- Address
- 3940 PENDLETON WAY INDIANAPOLIS IN 46226 US
- Phone
- 317-317-3175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SONOBLATE-500 | HIGH INTENSITY FOCUSSED ULTRASOUND | FOCUS SURGERY, INC. | MIK | SONOBLATE-500 | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-09-22 | 0 | 1. R |
Event Narratives#
D
Patient 1
MR. (B)(6) UNDERWENT HIGH INTENSITY FOCUSED ULTRASOUND TREATMENT OF THE PRO-STATE FOR PERSISTENT PROSTATE CANCER ON (B)(6) 2004. THREE WEEKS POSTOPERATIVELY HE DEVELOPED PROFUSE DIARRHEA AND WAS DIAGNOSED WITH A PROSTATIC RECTO-URETHRAL FISTULA. HE WILL NOW REQUIRE COLOSTOMY AND REPAIR.