MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-23 for SENSUS HEALTHCARE SRT-100 manufactured by Sensus Healthcare, Inc.
| Report Number | 3008513398-2019-00003 |
| MDR Report Key | 8927119 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-23 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-07-25 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2019-08-23 |
| 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 | MR KAL FISHMAN |
| Manufacturer Street | 851 BROKEN SOUND PARKWAY NW SUITE 215 |
| Manufacturer City | BOCA RATON FL 33487 |
| Manufacturer Country | US |
| Manufacturer Postal | 33487 |
| Manufacturer Phone | 5619225808 |
| Manufacturer G1 | RBM SERVICES |
| Manufacturer Street | 101-B VALLEY CT. |
| Manufacturer City | OAK RIDGE TN 37830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37830 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSUS HEALTHCARE SRT-100 |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2019-08-23 |
| Model Number | SRT-100 |
| Catalog Number | SRT-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSUS HEALTHCARE, INC |
| Manufacturer Address | 851 BROKEN SOUND PARKWAY NW SUITE 215 BOCA RATON FL 33487 US 33487 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-23 |