MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for PROTON RADIATION THERAPY manufactured by Unk.
[140434691]
My child was given proton radiation as treatment for medulloblastoma and unfortunately got radiation necrosis. This left her unable to sit up, walk, talk, see. We were given avastin and hyperbaric oxygen to help treat the damage but still damage exists. We were told odds for necrosis is 2-6% for getting radiation necrosis but, we found out it is actually 30% risk for radiation necrosis. We worry the reality of what is odds of radiation necrosis is not being tracked or followed and this is deadly. We want someone to be tracking instances of this as this still has the ability to kill her and would hate for this to happen to others. Seattle cancer care alliance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085298 |
| MDR Report Key | 8460747 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-19 |
| Date Added to Maude | 2019-03-28 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | PROTON RADIATION THERAPY |
| Generic Name | SYSTEM, RADIATION THERAPY CHARGED - PARTICLES MEDICAL |
| Product Code | LHN |
| Date Received | 2019-03-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2019-03-27 |