MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Radiation Burn (1755); Hearing Impairment (1881)

Event Date 06/14/2021

Event Type  Injury  

Event Description

Burns and hearing loss; (b)(6) was burned by an mri machine at (b)(6) on or about june 14, 2021.Fda safety report id# (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.
• MDR Report Key: 14566044
• MDR Text Key: 293187167
• Report Number: MW5110010
• 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: Attorney
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White