MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a unknown report with the FDA on 2004-09-22 for SONOBLATE-500 manufactured by Focus Surgery, Inc..
[26477188]
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.
Patient Sequence No: 1, Text Type: N, H10
[26477189]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951226-2004-00001 |
| MDR Report Key | 5095445 |
| Report Source | UNKNOWN |
| Date Received | 2004-09-22 |
| 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 Mfgr Received | 2004-09-14 |
| Date Added to Maude | 2015-09-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | NARENDRA SANGHVI |
| Manufacturer Street | 3940 PENDLETON WAY |
| Manufacturer City | INDIANAPOLIS IN 46226 |
| Manufacturer Country | US |
| Manufacturer Postal | 46226 |
| Manufacturer Phone | 3175411580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SONOBLATE-500 |
| Generic Name | HIGH INTENSITY FOCUSSED ULTRASOUND |
| Product Code | MIK |
| Date Received | 2004-09-22 |
| Model Number | SONOBLATE-500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 NA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2004-09-22 |