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

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/04/2019

Event Type  Injury  

Event Description

Pt had an mri performed on (b)(6) 2019.She incurred a what the radiologist stated as a probable 1st degree burn.The pt had a bright red area located on her right lower quadrant with an approximate size of 6cm.The pt immediately was treated with a cold compress and clear instructions by the radiologist dr (b)(6).Pt was sent home and was instructed to notify her provider if the symptoms or site increases in concern.On (b)(6) 2019, the mri technologist contacted the pt to get an update.The pt stated, "the bright red area was still there, but it decreased in size." pt was instructed to f/u with her provider if the area of redness increases or doesn't reduce.Fda safety report id# (b)(4).

• Brand Name: GE MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 9445870
• MDR Text Key: 170306118
• Report Number: MW5091553
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 132