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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTERNAL BEAM RADIATION MACHINE; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

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EXTERNAL BEAM RADIATION MACHINE; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Memory Loss/Impairment (1958); Visual Disturbances (2140); Viral Infection (2248); Anxiety (2328); Sleep Dysfunction (2517); Cognitive Changes (2551); Tics/Tremor (4425); Dry Mouth (4485); Alteration in Body Temperature (4568)
Event Date 01/15/2022
Event Type  Injury  
Event Description
(b)(6) radiation treatment: (b)(6) 2022 the nightmare started.Diagnosed with dcis stage 0 breast cancer, or pre-cancer , undergoing a minor lumpectomy, radiation treatment of right breast was recommended.A 5 fraction high dose 520cgy treatment given over 5 days; 520cgy is approximately twice the normal fraction dose.The second fraction (treatment) something felt wrong, (b)(6) stopped the procedure due to a panic attack.(b)(6) description of the panic attack noted after the second treatment which had to be stopped while (b)(6) recovered.After a few moments 2nd treatment was resumed.Radiation technician became irate at (b)(6) for the interruption and delay that panic attack caused.She required xanax to complete following fractions.She was warned of side effects due to radiation, (b)(6) was not warned of increased probability of side effects occurring due to a higher dose.Some effects she is experiencing are typical of breast radiation, but her problematic side effects are typical of head and neck radiation, she supposedly did not have.She was given a leaded blanket to shield vital organs in her abdomen, no type of shield was used to protect her head and neck.She experienced heat sensations on the right side of her neck and right ear.Catherine's disability: since radiation therapy she has had inability to regulate body temperature, fluctuations between upper body flushing and then cold with shivering tremors.Can repeat itself a number of times.Getting 2 to 4 hours total of frequently interrupted sleep per night.Shallow breathing, shortness of breath.Mouth and respiratory dryness.No saliva, mouth and throat are constantly dry.Tingling feeling down both arms and upper back.Tremors on left side.(right side brain affected by radiation?) tremors triggered by cold or being upset and become very strong her whole body shaking.Cognitive issues started approximately 2 weeks after radiation treatment.(b)(6) can't even do a simple puzzle, reading is difficult, vision is off.Tooth loss right side.(b)(6) has become so weak and is susceptible to tremors and thermalregulation issues she has drastically reduced her activities.No longer cooks meals, (done by her husband who has become her care taker.), not able to visit stores or restaurants, no longer visits the homes of friends or family.(b)(6) is basically house bound with the exception of being helped to a pre-warmed car for a daily ride.Prior to this she was a healthy active grandmother living a full life.Complaint boils down to these basic points.No shielding to protect the head and neck from stray radiation.Shielding was only used on abdomen.Since treatment the more severe side effects that are impacting (b)(6) are those that would occur if the head and neck were treated.It is our belief that a treatment accident occurred causing parts of (b)(6) body in the upper right quadrant to accidentally be irradiated.Parties responsible for (b)(6) treatment: (b)(6) oncologist dr.(b)(6) - a choice was offered between the standard of care which was a moderate hypofractionated regimen or the option of an ultrahypofractionated regimen (uk fast-forward).It is our understanding that this procedure is relatively new.Was it done properly? were the technicians trained properly regarding this new procedure? where was dr.(b)(6)? he was on vacation during the treatment he recommended and consequently did not oversee this new procedure.(b)(6) and their technicians at the treatment center - we question their training and experience as they were quite young.Roswell park and their treatment equipment suppliers - it has come to our attention that there can be equipment and computer programming errors caused by both the manufacturer and the operators of the radiation treatment equipment.While we have questioned dr.(b)(6), (b)(6) administrators, and others at (b)(6) about (b)(6) treatment and side effects, response from these parties has been dismissive, suggesting herbal remedies / anxiety medication as treatment.We are asking for an investigation of all parties, procedures, equipment used, personnel performance, and any other factors that could have caused such a debilitating disability.Please also refer to the side effect list below.Prior to radiation treatment (b)(6) had a normal active life.There is a stark day and night difference in her quality of life before / immediately after treatment.This document was completed by (b)(6) husband (b)(6).He is also her health care proxy.(b)(6) 2023 symptom / side effect list: none of these symptoms existed prior to radiation / covid radiation (b)(6) 2022) lung inflammation (pneumonitis) loss of salivation, extremely dry mouth, throat, lungs unable to clear phlegm because of dryness hot flashes, constant feeling of upper body being overheated, lower body and legs are cold flushing / redness of right side jawline and ear, (loss of capped tooth) pins / needles sensation down arms and upper back heart palpitations, tachycardia inability to concentrate food requirements: eat every 2-3 hours or get shaky weak and flushed covid (b)(6) 2022) decreased oxygen levels, increased shortness of breath intolerance to cold: uncontrollable shaking / shivering loss of thermoregulation (still intolerant of heat also) involuntary shaking / seizure like response to cold temperatures or strong emotions increased loss of concentration, further mental disability, memory loss inability to sleep more than 1-2 hours at a time at night impacted to a greater degree by covid due to a weakened immune system from radiation treatment.Smoking 1/2 pack / day, has had 3 children.
 
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Brand Name
EXTERNAL BEAM RADIATION MACHINE
Type of Device
SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
MDR Report Key16313229
MDR Text Key309260117
Report NumberMW5114755
Device Sequence Number1
Product Code MUJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Patient Sequence Number1
Treatment
ADVIL (OTC 200MG) 1 X DAY ; ALBUTEROL INHALER( ABOUT 1 PUFF 4 X DAILY: 2 DURING NIGHT 1-2 DAYTIME AS NEEDED ; LOTOMAX EYE DROP 0.5% (LEFT EYE)3 X WEEK ; MELATONIN 2.5 OR 5MG FOR SLEEP 1 X DAILY; METOCLOPRAMIDE (REGLAN) 1/2 PILL, 2.5 MG 1X DAY ; PEPCID 10MG (1/2 OF 20MG) 1 X DAILY; TAKEN DAILY:1
Patient Outcome(s) Disability; Life Threatening;
Patient Age67 YR
Patient SexFemale
Patient Weight70 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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