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

Device Problem Use of Device Problem (1670)

Patient Problem Tinnitus (2103)

Event Date 11/12/2022

Event Type  Injury  

Event Description

I was scheduled for 4 consecutive mris at (b)(6) in (b)(6).The tech gave me headphones to wear, which i incorrectly assumed were ear protective.I was not offered ear plugs.I was in the machine about 90 minutes.The next day i woke up with hyperacusis and i am suffering over two weeks later.Nobody can help me.I am bedridden, cannot sleep due to the tinnitus which us exacerbated by sounds of any kind.And will likely lose both my job and my sanity from this experience.Manufacturer unknown, contact (b)(6).Fda safety report id (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15906430
• MDR Text Key: 304867308
• Report Number: MW5113597
• 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: Patient
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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 Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White