MAUDE Adverse Event Report: GE HEALTHCARE COILS SPINE ARRAY COIL 1.5 T; COIL, MAGNETIC RESONANCE, SPECIALTY

Model Number 2416329

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/28/2024

Event Type  Injury  

Event Description

Patient is claiming a second degree burn after mri (magnetic resonance imaging) on posterior pelvic bone 4 in from spine.Patient reported event 11 days after exam and did not inform technologist of any events during exam.Patient has no known implants, there was a sheet between patient and coil.Patient did not have fingers or legs crossed and skin was not indirect contact with the machine.Patient was wearing medical shorts and his own long sleeve cotton shirt.

• Brand Name: SPINE ARRAY COIL 1.5 T
• Type of Device: COIL, MAGNETIC RESONANCE, SPECIALTY
• Manufacturer (Section D): GE HEALTHCARE COILS
• MDR Report Key: 18740162
• MDR Text Key: 335865079
• Report Number: MW5151781
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2416329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White