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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Superficial (First Degree) Burn (2685)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

This complaint aims to bring forward my painful visit to your office in (b)(6), on (b)(6) 2022.My experience was horrifying as i was burned in the mri machine.After constant reporting, i've recently been informed by attorney (b)(6) ((b)(6) that this incident was not reported to emergortho headquarters.It leaves me confused, and i don't understand why? i believe this is highly unethical as it has caused me severe physical and emotional damage and is a clear case of personal injury.Even though i was in severe pain and tears were rolling out of my eyes, i begged dr.(b)(6) to look at my back because i had been burned in the mri machine.He showed no empathy toward me.He didn't even look at me and stated that he was only concerned about the knee.Furthermore, he said he'd return me to work without restrictions and that i should have a good day.I have never experienced such an insensitive attitude at a clinic before.When i mentioned the burn to dr (b)(6) on my visit, he looked at my back and remained quiet.He stated that this was highly unusual and that the mri machine didn't burn people.However, he said that he would document it.He further stated that he's a surgeon and is returning me to work free from all restraints.Finally, he said he was going to request pain management for me.Unfortunately, as of today, i haven't had any pain management treatments.Since the day of the burn, "i" have undergone months of discomfort and stiffness and significant loss to my activities of daily living.My recovery period has been slow and excruciating.L haven't been able to sleep without soreness for months.The constant pain and lack of sleep have caused me great trouble.Since i suffered unnecessarily."i" would like to know that the technician, doctor, and workers comp adjuster who attended to me in your office have been reprimanded for this negligence.I appreciate your attention regarding this complaint, and i would be grateful if you look into the matter.I am willing to provide all the necessary information to help with this.

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 15987061
• MDR Text Key: 305593431
• Report Number: MW5113796
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American