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U.S. Department of Health and Human Services

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

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MRI MEDICAL IMAGING; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Radiation Overexposure (3017)
Patient Problems Radiation Overdose (1510); Loss of Vision (2139); Loss of consciousness (2418); Vitreous Detachment (2445); Cancer (3262)
Event Date 08/04/2009
Event Type  Injury  
Event Description
Allegation: (to medical board of (b)(6)) i allege that mr.(b)(6), (hospital-medical provider, license (b)(6)) has done medical negligence on me during the 4-days er-hospitalized in (b)(6) medical center (b)(6) on (b)(6) 2009.This medical negligence has caused my skin-mass, left eye flashes of light, degeneration - earlier organs in my head area; currently has caused my left eye out-vision for long.Here is the brief of timeline: 2009: (b)(6), 1st ct scan in er after 911 - ambulance.On (b)(6) 2009, 2nd mri scan in room.On (b)(6) 2009, 3rd mri scan in truck.(this was repeated overuse mri, excess doses).On (b)(6) 2009, discharged from (b)(6).On (b)(6) 2010: (b)(6) primary provider dr.(b)(6) health examination and reviewed all copies of (the 4-days er - hospitalized) medical record.My shoulder skin mass and my left eye flashes of light had occurred for a few days.His opinion on the 4-day-in-(b)(6): transient loss of consciousness, no-stroke-occurred.I had doubted that.On (b)(6) 2010 (b)(6) optometry, dr.(b)(6) eye examination: my eyes vitreous detachment and glaucoma.And he told me "left eye will become blind and no cure".I was not even believing at that time.On (b)(6) 2012: (b)(6) surgery, (b)(6) md: removed a lipoma/ the skin mass on my shoulder.On (b)(6) 2014: left eye out-vision suddenly at work (my employer: (b)(6) for verification).At the moment i began to believe dr.(b)(6) medical decision; i was shocking and feeling no-cure.On (b)(6) 2017: (b)(6) ophthalmology, dr.(b)(6) eye examination: my eyes retinal detachment, glaucoma, and degeneration.Left eye out-vision for long.This damage from medical negligence occurred beyond the statute of limitations; and the sequelae of overuse mri as excess doses has been continually lasting.From my simple living life, i believe that dr.(b)(6) decision is accurate; there was no stroke.Statue of limitations doesn't limit overuse radiology, doesn't limit medical mistreat, and doesn't limit out-vision of my left eye (eeoc, disability); therefore, i request the (b)(6) investigate this matter.Complainant: (b)(6).On 2018 (all original medical records keeping) brief of totally four-time-brain-scanning: (4-day er/h in 2009) 1st, ct: computer tomography, x-ray (in er at night) 2nd, mri: magnetic resonanced imaging, radiology.(in a room w/o injection at night), 3rd, mri: (twice inside a truck with and w/o injection in the morning) (overuse mri caused mri-radiation-overdoses.) mri radiation-overdoses effect: 6 months later: l-shoulder skin mass.L-eye flash of light.One year and 5 months later: l-eye retinal detachment (eye condition).Five years later: l-eye total retinal detachment (as blind for my rest of life).(b)(6) code of civil procedure 340.5 in an action for injury or death against a health care provider based upon such person's alleged professional negligence, the time for the commencement of action shall be three years after the date of injury or one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first.In no event shall the time for commencement of legal action exceed three years unless tolled for any of the following: upon proof of fraud, intentional concealment, or the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.Mri radiation overdose, result.
 
Event Description
Add'l info received from reporter on 05/02/208 for report # mw5076896.Re: mri risk: (related points articles from www.Fda.Com 2018).(article 1) medical x-ray imaging (updated: 03/06/2017) risks potentially cause damage to dna.Risks from exposure to ionizing radiation include: a small increase in the possibility that a person exposed to x-rays will develop cancer later in life.Tissue effects such as cataracts, skin reddening, and hair loss, which occur at relatively high levels of radiation exposure and are rare for many types of imaging exams.Info for health care providers the fda recommends that health care professionals and hospital administrators take special care to reduce unnecessary radiation exposure by following these 3 strips: referring physicians should: reduce the number of inappropriate referrals (i.E., improve justification of x-ray imaging exams) by: considering alternative examinations that use less or no radiation exposure, such as ultrasound or mri, if medically appropriate; and checking the pt's medical imaging history to avoid duplicate examinations.Hospital admins should: ensure that the principles of radiation protection are incorporated into the facility's overall qa program.(article 3) fda alert: [6/2006, updated 2007] after they received a gadolinium-based contrast agent during a magnetic resonance imaging scan (mri) or magnetic resonance angiography (mra).The signs are symptoms of nsf/nfd include: for the skin-burning or itching, reddened or darkened patches, and/or skin swelling, hardening and/or tightening for the eyes-yellow raised spots on the whites of the eyes; for the bones, joints and muscles - joint stiffness; limited range of motion in the arms, hands, legs, or feet pain deep in the hip bone or ribs, and/or muscle weakness.
 
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Brand Name
MRI MEDICAL IMAGING
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key7472705
MDR Text Key107208984
Report NumberMW5076896
Device Sequence Number2
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 08/24/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age53 YR
Patient Weight75
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