MAUDE Adverse Event Report: PROTON RADIATION THERAPY ; SYSTEM, RADIATION THERAPY CHARGED - PARTICLES MEDICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Visual Impairment (2138); Dysphasia (2195); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

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.

• Brand Name: PROTON RADIATION THERAPY
• Type of Device: SYSTEM, RADIATION THERAPY CHARGED - PARTICLES MEDICAL
• MDR Report Key: 8460747
• MDR Text Key: 140434691
• Report Number: MW5085298
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability