BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELENIA MAMMOGRAPHY SYSTEM

    MDR report key: 2491437 · Received March 7, 2012

    Report

    Report Number
    1220984-2012-00002
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    March 5, 2012
    Manufacturer
    HOLOGIC, INC.
    Product Code
    GEI
    PMA / PMN Number
    P010025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SELENIA SYSTEM WAS EVALUATED BY AN HOLOGIC FIELD ENGINEER ON FEBRUARY 08, 2012, AND WAS FOUND TO BE WORKING PROPERLY. THE SELENIA SYSTEM FUNCTIONED AS DESIGNED. THE FIELD ENGINEER ADJUSTED PADDLE RECEPTOR AND CARRIAGE SPEED TO ACCOMMODATE USER PREFERENCE. HOLOGIC HAS SCHEDULED A VISIT TO THE SITE BY AN APPLICATIONS SPECIALIST ON MARCH 08, 2012. THIS VISIT IS TO ENSURE THE TECHNOLOGISTS AT THE SITE ARE USING THE SYSTEM CORRECTLY AND TO REVIEW THE OPTIONS AVAILABLE TO AVOID USING THE MANUAL HAND CRANK FEATURE. THIS IS A RARE OCCURRENCE. REPORTS OF THIS TYPE ARE LIMITED TO THIS CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNOLOGIST WAS OUT ON DISABILITY FOR WRIST INJURY. THIS INJURY IS ALLEGEDLY FROM THE USE OF THE MANUAL CARRIAGE CRANKING FEATURE AND PADDLE RECEPTOR BEING TOO TIGHT IN CARRIAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM GEI HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability