FDA Adverse Event Injury Summary report: N

GENERAL ELECTRIC

MDR report key: 20399693 · Received October 7, 2024

Report

Report Number
MW5160800
Event Type
Injury
Date Received
October 7, 2024
Date of Event
August 30, 2024
Report Date
October 2, 2024
Manufacturer
GE HEALTHCARE MANUFACTURING LLC
Product Code
LNH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A PATIENT SCANNED (B)(6) 2024 ON THE 3T GE DISCOVERY CAME IN (B)(6) 2024 TO NOTIFY THE IMAGING MANAGER THAT DURING THIS SCAN SHE OBTAINED A THERMAL BURN LOCATED ON HER LOWER BACK. THIS WAS A BREAST MRI AND THE SENTINELLE 16CH BREAST COIL WAS USED. SHE HAS PROVIDED PICTURES DOCUMENTING THE STAGES AND PROGRESSION OF THE BURN. THE PATIENT, WHO HAS A LARGE BODY HABITUS, WAS SCANNED IN THE PRONE POSITION AND HER BACK SIDE WAS TOUCHING THE TOP OF THE BORE. THE PATIENT WAS CHANGED INTO A HOSPITAL GOWN BEFORE ENTERING THE ROOM. SHE DID HAVE PADDING AT EACH SIDE OF HER ARMS; HOWEVER, PADDING WAS NOT USED ON HER BACK DUE TO LACK OF AIR SPACE. THE PATIENT DID MENTION THAT HER BACK HURT AND THAT SHE FELT HOT WHICH THE TECH ASSUMED WAS DUE TO THE POSITION AND NATURE OF THE EXAM. THE TECH DID STOP THE EXAM, REMOVE THE PATIENT FROM THE BORE AND ASK IF SHE WOULD LIKE TO PROCEED OR ABORT THE SCAN, AT WHICH TIME THE PATIENT AGREED TO PROCEED IN AN EFFORT TO COMPLETE THE TEST. AT NO TIME DID THE PATIENT MENTION TO THE TECH THAT SHE FELT A BURNING SENSATION ANYWHERE ON HER BODY. AFTER COMPLETING THE TEST, THE PATIENT WAS CRYING WHICH THE TECH ATTRIBUTED TO POSITIONAL DISCOMFORT, SHE THEN DRESSED AND LEFT THE FACILITY WITHOUT MENTIONING A POSSIBLE BURN OR LINGERING DISCOMFORT IN A LOCALIZED AREA. THE TECH HAD NO IDEA THAT THERE WAS ANY REASON FOR CONCERN AND NO NOTES WERE DOCUMENTED IN THE CHART REGARDING THE INCIDENT. THE PATIENT IMMEDIATELY LEFT THE IMAGING DEPARTMENT AND CONSULTED WITH HER ORDERING PHYSICIAN WHO NOTED IN THE CHART "POSSIBLE BURN VS POTENTIAL ALLERGIC REACTION." THE PATIENT WAS ADVISED TO MONITOR THE AREA AND PROCEED TO THE EMERGENCY ROOM IF SYMPTOMS WORSENED. THE AREA WAS BLISTERED THE DAY AFTER THE APPOINTMENT CONFIRMING IT WAS ACTUALLY A BURN. THE PATIENT STATES THAT SHE WAS EVENTUALLY URGED BY DR. (B)(6) TO MAKE A FORMAL COMPLAINT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
335768 GENERAL ELECTRIC SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC MR750W

Patients

Seq Age Sex Outcome Treatment
1 41 YR Female Other