BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC SELENIA MAMMOGRAPHY EQUIPMENT

    MDR report key: 17492525 · Received August 8, 2023

    Report

    Report Number
    MW5122831
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 4, 2023
    Manufacturer
    HOLOGIC IN
    Product Code
    MUE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN MLO POSITION COMPRESSION PADDLE RELEASED INTO FACE SHIELD PINCHING THE PATIENT'S CHIN IN BETWEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688943 HOLOGIC SELENIA MAMMOGRAPHY EQUIPMENT FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC MUE HOLOGIC IN SELENIA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female