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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI

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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Irritation (1941); Pain (1994); Respiratory Distress (2045); Burning Sensation (2146); Ambulation Difficulties (2544); Polydipsia (2604); No Code Available (3191)
Event Date 10/18/2017
Event Type  Injury  
Event Description
Status post traumatic brain injury, patient had an mri which was requested by dr. (b)(6). Mri was performed at (b)(6) in (b)(6). Patient was told to wear her regular clothing inside the machine. Patient began to feel extremely hot and felt like she was being boiled. She was about to press the panic button when the mri recycled and the sensation stopped. Unfortunately, the burning sensation returned again during another cycle. Immediately following the mri, she experienced ambulation difficulties. Her tongue was stuck to the roof of her mouth. Two hours post mri patient spoke to the er nurse due to pain, extreme thirst and erythema. She experienced difficulty swallowing and felt that items were caught in her throat. She went to the er twice and was refused treatment due to the mention of the mri being the causative agent. Patient was seen by an ent doctor and found irritation of the eyes, ears, nose and vocal cords which were permanently damaged. Her vision is getting worse. Her gastroenterologist requested an upper and lower gi due to a dark bm post mri. She has severe head pain and the eeg tech had difficulty placing electrodes due to sores in her scalp. She has blisters in her mouth, nose and scalp. She has excruciating pain. Patient saw a dermatologist who confirmed erythema. She cannot consume spice, enter the sunlight, or take warm showers. She feels like she is baking from the inside out. She has respiratory difficulties and wants to be seen by a pulmonologist. Patient also complained concerning the technologist's inappropriate line of questioning related to her breast post reduction surgery.
 
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Brand NameMRI
Type of DeviceMRI
MDR Report Key7095484
MDR Text Key94354157
Report NumberMW5073791
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
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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