MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for WHOLE BRAIN RADIATION THERAPY 37.5 GY IN 15 FRACTIONS manufactured by .
[113006278]
Pt was treated on protocol rtog 1119 standard of care (arm 1) with wbrt. Pt was treated (b)(6) 2018 at 8:05am. She received 6 fractions of rt. Per radiation therapist, pt did not endorse any specific complaints and did not request to see a physician before leaving clinic. According to ed report, ems was called to pt due to sob, chest pain, and syncope the evening of (b)(6) 2018. Ems performed cpr and administered epinephrine on site and transported pt to ed in cardiac arrest. Resuscitation was attempted and epinephrine, sodium bicarbonate, calcium chloride, and amiodarone were all administered in the ed. Pt was pronounced deceased at 8:39pm. Cause of death is listed as presumed pe but there is no supporting imaging to confirm. Therapy start date: (b)(6) 2018, therapy end date: (b)(6) 2018. Diagnosis or reason for use: brain mets.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078174 |
| MDR Report Key | 7654283 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-21 |
| Date Added to Maude | 2018-07-02 |
| 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 | WHOLE BRAIN RADIATION THERAPY 37.5 GY IN 15 FRACTIONS |
| Generic Name | RADIATION THERAPY |
| Product Code | LHN |
| Date Received | 2018-06-29 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2018-06-29 |