BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTON DEAN MEDICAL

    MDR report key: 46698 · Received September 20, 1996

    Report

    Report Number
    1720804-1996-00001
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 27, 1996
    Report Date
    September 13, 1996
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PRESSURE IRRIGATOR DOOR/COVER CRACKED UNDER PRESSURE OF APPROX. 550MLHG. A PIECE OF THE DOOR FULLY SEPARATED FROM THE COVER ALONG THE BOTTOM HALF OF THE LATCH SIDE OF THE DOOR & "FLEW ACROSS THE FLOOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN MEDICAL PRESSURE IRRIGATOR KZD ALTON DEAN MEDICAL, INC. SI-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other