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

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956); Protective Measures Problem (3015)

Patient Problems Tinnitus (2103); Distress (2329)

Event Date 04/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 at approximately 8:45am i had an enclosed mri scan conducted at the (b)(6) hospital in (b)(6) on my skull and face regarding tmj concerns.I was given ear plugs by the technologist; however, i was not properly instructed on how to insert the ear plugs correctly in my ear and as a result my existing tinnitus has now been exacerbated.I was given gauze to put in my mouth during the procedure as well as my head was placed in a cubicle like box.The gauze was removed, and however as the procedure progressed the sound became increasingly loud, i guess due to the fact that the earplugs were not properly installed inside of my hear on behalf of the negligence of the one technologist.After 5 minutes or less, i had them stop the procedure, the technologist then became increasingly agitated, but my concern was about the protection of my ears.Eventually, another technologist who actually assisted the negligent technician as if he was in training, was finally able to instruct me on how to properly insert the ear plugs.Although, she was able to insert them, i still believe however they were still not properly inserted simply because my hearing has not been the same since with constant ringing and distress.I spoke to (b)(6) imaging department manager (b)(6) regarding this and he also agreed the tech was completely negligence and should have took better precautions in making sure those ear plugs were correctly installed.(b)(6) also informed me that the earmuff/headphone system was actually down that day, which if i had known this information prior to the procedure i would have never gone through with the mri.

• Brand Name: MAGNETIC RESONANCE IMAGING
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 16771284
• MDR Text Key: 313679267
• Report Number: MW5116849
• 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: 04/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American