MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-18 for DOSECHECK (PART OF SUNCHECK) DOSECHECK X 1.3.2 DOSECHECK BUILD 17114 manufactured by Sun Nuclear Corporation.
| Report Number | MW5088230 |
| MDR Report Key | 8807351 |
| Date Received | 2019-07-18 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-07-11 |
| Date Added to Maude | 2019-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DOSECHECK (PART OF SUNCHECK) |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IYE |
| Date Received | 2019-07-18 |
| Model Number | DOSECHECK X 1.3.2 |
| Catalog Number | DOSECHECK BUILD 17114 |
| Lot Number | SUNCHECK BUILD 17114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUN NUCLEAR CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-18 |