MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-11-12 for FLEXITRON HDR manufactured by Nucletron B.v..
| Report Number | 9611894-2019-00003 |
| MDR Report Key | 9309326 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date Mfgr Received | 2019-10-14 |
| Date Added to Maude | 2019-11-12 |
| 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 | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | NUCLETRON B.V. |
| Manufacturer Street | WAARDGELDER 1 |
| Manufacturer City | 3905TH |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3905 TH |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITRON HDR |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2019-11-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON B.V. |
| Manufacturer Address | WAARDGELDER 1 3905TH NL 3905 TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-12 |