BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON OVAL

    MDR report key: 13688518 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00010
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    March 18, 2021
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING ECHELON OVAL MRI. THE SITE REPORTED THAT A PATIENT RECEIVED A HIP MRI ON (B)(6) 2021 AND STATED AFTER THE SCAN THAT HE HAD RECEIVED TWO BURNS ON HIS RIGHT AND LEFT INNER THIGHS THE SIZE OF A QUARTER. THE PATIENT REPORTED THAT THE REDNESS WAS LESS AT THE END OF THE DAY (DAY OF EXAM) BUT THERE WERE PIN HEAD SIZED BLISTERS ON BOTH LEGS IN THAT AREA (3 ON RIGHT, 2 ON LEFT) THAT EVENING. THE NEXT DAY (B)(6) HE STATED THE BLISTERS WERE SCABBED OVER AND IMPROVING, AND SAID HE WAS OK. PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION FOR THE BURNS MANAGEMENT. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670880 ECHELON OVAL MAGNETIC RESONANCE DIAGNOSTIC DEVICE. LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other