MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-12 for SUNCHECK - DOSECHECK MODULE V1.3.2 manufactured by Sun Nuclear Corporation.
| Report Number | 1038814-2019-00001 |
| MDR Report Key | 8884913 |
| Date Received | 2019-08-12 |
| Date of Report | 2019-08-09 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-07-11 |
| Date Added to Maude | 2019-08-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES LUKER |
| Manufacturer Street | 3275 SUNTREE BLVD |
| Manufacturer City | MELBOURNE FL 32940 |
| Manufacturer Country | US |
| Manufacturer Postal | 32940 |
| Manufacturer Phone | 3212596862 |
| Manufacturer G1 | SUN NUCLEAR CORPORATION |
| Manufacturer Street | 3275 SUNTREE BLVD |
| Manufacturer City | MELBOURNE FL 32940 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32940 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUNCHECK - DOSECHECK MODULE |
| Generic Name | RADIOLOGIC QUALITY ASSURANCE INSTRUMENT |
| Product Code | IYE |
| Date Received | 2019-08-12 |
| Model Number | V1.3.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUN NUCLEAR CORPORATION |
| Manufacturer Address | 3275 SUNTREE BLVD MELBOURNE FL 32940 US 32940 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-12 |