BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENOGRAPHE 2000D

    MDR report key: 1552248 · Received December 4, 2009

    Report

    Report Number
    9611343-2009-00059
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    November 6, 2009
    Report Date
    November 6, 2009
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    MUE
    PMA / PMN Number
    P990066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AFTER A LEFT MEDIOLATERAL OBLIQUE (MLO) VIEW DURING A MAMMOGRAPHY EXAM, THE PATIENT ALLEGEDLY "COLLAPSED" AND WAS CONSEQUENTLY CAUGHT BETWEEN THE COMPRESSION PADDLE AND THE FACE PROTECTION SHIELD. A HOSPITAL STAFF ATTEMPTED TO HELP THE PATIENT THAT REPORTEDLY LED TO PATIENT RECEIVING A CUT, APPROXIMATELY 2 TO 3CM IN SIZE, BEHIND HER LEFT EAR. AT THIS TIME, IT IS NOT CLEAR WHAT CAUSED THE "COLLAPSE" OR HOW THE PATIENT OBTAINED THE CUT. GE HEALTHCARE IS CURRENTLY ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION TO UNDERSTAND THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENOGRAPHE 2000D MUE GE MEDICAL SYSTEMS S.C.S. 2298472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other