BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRE HD PLUS, ASPIRE HD-S

    MDR report key: 17711254 · Received September 8, 2023

    Report

    Report Number
    3001722928-2023-00053
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 10, 2023
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    MUE
    PMA / PMN Number
    K121674
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN OCTOBER 1, 2021 AND OCTOBER 12, 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON SEPTEMBER 22, 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Additional Manufacturer Narrative · 0

    THE FACILITY BELIEVES THE PATIENT'S RIGHT EYEBROW HIT A FOOTSWITCH ON THE FLOOR. THE NURSE SAID THE PATIENT HAD BEEN UNWELL FROM THE TIME THE BLOOD WAS DRAWN BEFORE THE MAMMOGRAM WAS TAKEN. THE RADIOLOGIST LATER CONFIRMED THAT THE PATIENT HAD NO PAIN DURING THE MAMMOGRAM ITSELF. FUJIFILM DETERMINED THAT THE CAUSE OF THE ADVERSE EVENT WAS THE PATIENT'S CONDITION.

    Description of Event or Problem · 0

    ON (B)(6) 2023 FUJIFILM CORPORATION WAS INFOMRED OF AN EVENT INVOLVING FDR MS-2000. AFTER A MAMMOGRAM, THE PATIENT HAD A VAGAL REFLEX, COLLAPSED, AND LOST CONSCIOUSNESS. WHEN FALLING, THE PATIENT HIT NEAR THE RIGHT EYEBROW, RESULTING IN A CUT OF APPROXIMATELY 1 CM. THE WOUND WAS SUTURED. THERE WAS NO DEATH REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112746 ASPIRE HD PLUS, ASPIRE HD-S ASPIRE HD PLUS, ASPIRE HD-S MUE FUJIFILM CORPORATION FDR MS-2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention