MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for DRUG/BIOLOGIC RADIATION THERAPY manufactured by Unknown.
[183517081]
On (b)(6) 2020, the patient reported to crc that he was hospitalized on (b)(6) 2020. Reports determine the patient was dehydrated. The patient received iv fluids, potassium, and magnesium. The patient was discharged to his home in stable condition on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093669 |
| MDR Report Key | 9818366 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| 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 | 3 |
| Brand Name | DRUG/BIOLOGIC RADIATION THERAPY |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2020-03-10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-10 |