FDA Adverse Event Injury Summary report: N

MRI SCANNER

MDR report key: 11596146 · Received March 30, 2021

Report

Report Number
MW5100427
Event Type
Injury
Date Received
March 30, 2021
Date of Event
March 18, 2021
Report Date
March 29, 2021
Manufacturer
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP
Product Code
LNH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
501

Narratives

Description of Event or Problem · 1

PATIENT WAS UNDERGOING AN MRI SCAN OF THE RIGHT HIP. WHEN THE PATIENT WAS TAKEN OUT OF THE SCANNER AT THE COMPLETION OF THE EXAM, HE REPORTED TO THE TECHNOLOGIST THAT HIS UPPER THIGHS FELT LIKE THEY WERE BURNING. UPON INSPECTION OF THE PATIENT, TWO SMALL RED CIRCLES WERE PRESENT ON HIS INNER THIGHS WHERE THEY WERE TOUCHING, AND HE HAD BURNING PAIN PRESENT IN THAT AREA. AT THAT TIME, THE PATIENT DID NOT REQUEST MEDICAL TREATMENT AND LEFT THE FACILITY. THE NEXT DAY A FOLLOW UP CALL WAS PERFORMED. THE PATIENT STATED THE REDNESS WAS LESS AT THE END OF THE DAY (DAY OF EXAM), BUT THERE WERE PIN HEAD SIZE BLISTERS ON BOTH LEGS IN THAT AREA (3 ON RIGHT AND 2 ON LEFT) THAT EVENING. THE NEXT DAY (3/18) HE STATED THE BLISTERS WERE SCABBED OVER AND IMPROVING, AND SAID HE WAS OK. HE DID NOT INDICATE HE NEEDED TO SEEK MEDICAL TREATMENT. ANOTHER ATTEMPT WAS MADE TO CONTACT THE PATIENT A WEEK LATER, BUT HE DID NOT RETURN PHONE CALL. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
490158 MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP ESCHELON OVAL

Patients

Seq Age Sex Outcome Treatment
1 64 YR