MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-26 for SONABLATE manufactured by Focus Surgery, Inc..
| Report Number | 2951226-2019-00001 |
| MDR Report Key | 9124115 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-26 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-08-30 |
| Device Manufacturer Date | 2016-10-27 |
| Date Added to Maude | 2019-09-26 |
| 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 | MS. JANE DOLL |
| Manufacturer Country | US |
| Manufacturer Phone | 3175411580 |
| Manufacturer G1 | FOCUS SURGERY, INC. |
| Manufacturer Street | 4000 PENDLETON WAY |
| Manufacturer City | INDIAPOLIS IN 46226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONABLATE |
| Generic Name | HIGH INTENSITY FOCUSED ULTRASOUND DEVICE |
| Product Code | PLP |
| Date Received | 2019-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS SURGERY, INC. |
| Manufacturer Address | 4000 PENDLETON WAY INDIANAPOLIS IN 46226 US 46226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-26 |