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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burning Sensation (2146)

Event Date 10/04/2021

Event Type  Injury  

Event Description

Patient completed lumbar mri study and began experiencing internal burning under his right rib approximately 30 minutes after study was completed.Patient had no contact with coil or machine.Patient had been medically cleared to proceed with mri with all implants on the safe list, patient has no implants where burning was indicated.Fda safety report id # (b)(4).

• Brand Name: MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 12589930
• MDR Text Key: 275429278
• Report Number: MW5104443
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 112