BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS

    MDR report key: 10733174 · Received October 26, 2020

    Report

    Report Number
    10733174
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 15, 2020
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERFORMING A BASELINE MAMMOGRAM, FIRST IMAGE WAS LOWERING COMPRESSION, THE COMPRESSION PADDLE POPPED/CRACKED. PATIENT WAS STARTLED AND SHE SAID IT DID PINCH HER UPPER CHEST. I REMOVED THE COMPRESSION PADDLE FROM THE ROOM. I APOLOGIZED, SHE SAID SHE WAS OK, I CHECKED HER BEFORE SHE LEFT, NOTICED NO BRUISING BUT A RED MARK WAS PRESENT ON THE RIGHT UPPER CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197715 SELENIA DIMENSIONS FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC MUE HOLOGIC, INC. ASY-01945

    Patients

    Seq Age Sex Outcome Treatment
    1 14600 DA