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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Contamination /Decontamination Problem (2895)
Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Burning Sensation (4540)
Event Date 06/01/2023
Event Type  Injury  
Event Description
I came from (b)(6), and this is not the first time i have done tests there.They are aware of my physique when i make an appointment.Today's mri(magnetic resonance imaging) femur right without contrast lasted a very long time.The technician was new (i hadn't seen it before when i went).She gave me the gown, told me to remove everything except underwear, and put my stuff in the closet, and took me to the room! then she asked me (maybe you would reschedule to another location? they have a bigger machine.I told her that i was doing mri tests every year here.She said, you were doing on (b)(6) last year(i was doing the second time mri 3t for the liver and gallbladder due to new nodules finding, and you can check yourself.) after our conversations, she took me into a room where water drops were on the ceiling! water drops were all over the ceiling from the left side of the mri machine.It must have been a leak.The machine was ancient with a broken scoreboard.It's on top of the machine, and two old screws were sticking out instead of a screen.The mri began, and the lady suggested that i move tightly to the left side-i did it! in the middle of the mri, the heat started to come out on the left side.I endured, then i shifted to the right during the test.It was an extended test.When everything was over, the lady approached me, and i told her it was hot air from the left side.She pulled up my gown, looked at my left side, and asked (are you ok?) i told her, finally, it is over.But my back was killing me, and she did help me to get off.I came home, changed the dress and i felt a burning pain on the left side and saw an intense burn- a blister had already come out.The first time i have had this)) i got a burn, and it was all in the same old mri machine -there was never such a thing in all my tests before.I got more pain, started calling them, and asked for the manager.And the manager already knew what for i was calling.Her name was (b)(6)-she is a manager, what she said shocked me.The way she was lying, (nothing wrong with her machine, no leak, no broken machine, nothing! and also, the technician offered you to go to the different locations (it means rescheduling the appointment).She denied everything (she doesn't have water drops next to the mrimachine, no leaks in this room, no old machine-not properly working machines, nothing! and nothing about my huge painful burns-blister, unsanitary & health hazards, so disrespectful, unprofessional, and utterly indifferent to my (anybody's) health.I am in pain with a blister.I don't know what to use for it.I wrote and sent pictures to my doctor to get treatment for this burn with a blister.Please, this is a life-threatening situation.If manager (b)(6) doesn't care and talks to you and lies to you ( what can i do with them ?), i have enough pain, and now i got more from this place.Please help me out.Please inspect this unsanitary, with water drops next to the old /not working properly mri machine where patients getting burned with blisters.If i hadn't so many health issues i would not go there, now on top of my pain with my health problems i got from them this painful burns with blisters.Please help me out, please inspect this place and manager itself, the way she takes care of people and lies to them.Cervical and lumbar spondylosis with radiculopathy's, degenerative disc disease, cervical&lumber herniation, scoliosis, carpal tunnel syndrome in both hands, depression, fibromyalgia, the right hip edema, thoracic disc herniation, cyst of the left kidney, severe back/lower back/coccyx/buttocks/thigh/calf/neck stiffness, headaches for several days, internal&external hemorrhoids, morbid obesity, constipation, thyroid nodules, obstructive sleep apnea, gouty arthritis of both feet, elevated the uric acid, chronic renal insufficiency, nodules in gallbladder, chronic fatigue syndrome, loss of balance, symptomatic varicose veins bilateral, djd(degenerative joint disease) of both hips and knees symmetrically, heart palpitations, essential hypertension, artery stenosis.Thank you, (b)(6).
 
Event Description
Additional information received on 06/07/2023 from the reporter for the report #mw5118179.I got burned from mri's not working equipment; fraudulent report, scammers / negligent / unethical / unprofessional workers.Hello, my name is (b)(6).I have been scheduled for the mri of femur right without contrast at (b)(6) at 8 am on (b)(6) 2023.This mri femur right without contrast lasted a very long time (by checking my phone, i did text my sister at 7:23 am (they took me), and soon as i got to the dressing room, i did text her again at 8:26 (i just came out).I was shocked.I hardly got there due to my pain, my cervical and lumber problem, and my hip-legs (she surprised me with her questions after i put on the gown and was ready for mri).And real (b)(6) today gave me the name of the manager of this radiology location ((b)(6)) and the name of the technician who did the mri for me ((b)(6)).And gave me phone numbers for the pt's services and manager's phone number so that i let them know how i got burned and how i was treated.When she lifted my gown, this technician saw the burn, but she didn't tell me or provide first aid.How to call it all - you know better.And the worst thing is that i received an mri report on the evening of (b)(6) 2023.This is the biggest joke in their report, fraud report: i have edema, but over 2+ years, my entire right leg has deteriorated and doubled in size compared to my left leg.Moreover, it hurts.These scammers lie, refuse everything that happened, introduce themselves as another title and name, and still give a false mri report.Even the healthiest wouldn't have this kind of mri report without any problems.This false mri report from the broken / old equipment shows no change in my swollen, painful right leg.I was left with a painful burn and a false mri report from the broken, faulty mri machine.I called my (b)(6) insurance company and let them know what happened.They burned me and left without an mri.On 06/01/2023, i complained to the city (i didn't have the strength to write and describe it all), i started today.I have no words.This radiology hurts mentally and physically.These people should not work anywhere and shouldn't have a license.They are scammers / liars / negligent / unprofessional / unethical - they shouldn't be around people.Please investigate my situation, and please take action against these scammers.I've attached pictures of my burning with a blister, an mri of the right hip from 2021, and a fraudulent mri report from this place as of (b)(6) 2023.
 
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Brand Name
MRI MACHINE
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key17071035
MDR Text Key316697385
Report NumberMW5118179
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2023
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
AIMOVIG ; ALLOPURINOL; BUPROPION; CANE; CLONAZEPAM ; COMPLEX VITAMIN B12; COQ10; DICYCLOMINE ; DOXEPIN; ESSENSIELLE FORTE; LYRICA; MAGNESIUM; METOPROLOL; NAPROXEN; NURTEC OTD; OMEGA; PSP 50; SELENIUM; SILYMARIN; TIZANIDINE; TRAMADOL; TRIAMTERIN; VITAMIN D. ; VITAMIN E
Patient Outcome(s) Life Threatening; Required Intervention; Other;
Patient Age51 YR
Patient SexFemale
Patient Weight145 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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