MAUDE Adverse Event Report: GENERAL ELECTRIC 3T DISCOVERY 750 MRI GE; SYSTEM, NUCLEAR MAGNETIC RESONNENCE IMAGING

Device Problem Insufficient Information (3190)

Patient Problems Radiation Burn (1755); Erythema (1840); Burning Sensation (2146)

Event Date 02/15/2018

Event Type  No Answer Provided  

Event Description

Pt had mri of prostate on 3t scanner (ge discovery 750) for about 30 min.During the exam he felt burning sensation on his right lower leg above the knee cap outer side.Later that night he noticed redness, like sun burn in three areas about one inch in size.No blisters or break skin noted, but there is darkened area per pt.Pt was advised to seek medical attention for the burned skin.He is treating burn with aloe vera, per his dr's instruction.

• Brand Name: 3T DISCOVERY 750 MRI GE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONNENCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC
• MDR Report Key: 7302343
• MDR Text Key: 101279085
• Report Number: MW5075559
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 87