MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-14 for SONOLATE-500 SONOBLATE-500 manufactured by Focus Surgery, Inc..
[27925872]
Mr. (b)(6) underwent high intensity focused ultrasound treatment of the prostate for persistent prostate cancer on (b)(6) 2004. Three weeks postoperatively, he developed profuse diarrhea and was diagnosed with prostatic recto-urethral fistula. He will now require colostomy and repair. The hifu device, sonablate-500 is under ide study. The adverse event is an anticipated event. The ide study (b)(4) is now closed enrolling patients as it has completed allowable number for the study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5137152 |
| MDR Report Key | 5137152 |
| Date Received | 2004-09-14 |
| Date of Report | 2004-09-09 |
| Date of Event | 2004-08-21 |
| Date Facility Aware | 2004-08-21 |
| Report Date | 2004-09-09 |
| Date Reported to FDA | 2004-09-14 |
| Date Reported to Mfgr | 2004-09-14 |
| Date Added to Maude | 2015-10-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SONOLATE-500 |
| Generic Name | HIGH INTENSITY FOCUSED ULTRASOUND |
| Product Code | NRZ |
| Date Received | 2004-09-14 |
| Model Number | SONOBLATE-500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS SURGERY, INC. |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-14 |