BEUDAMED
    FDA Adverse Event Other Summary report: N

    B.C.M.

    MDR report key: 16458 · Received January 10, 1994

    Report

    Report Number
    2020563-1993-00014
    Event Type
    Other
    Date Received
    January 10, 1994
    Date of Event
    November 2, 1993
    Report Date
    November 9, 1993
    Manufacturer
    B.C. MEDICAL
    Product Code
    IZP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER MAY HAVE OVERRIDDEN DOOR INTERLOCK SENSOR WHILE CYCLING THE MACHINE, RESULTING IN FRACTURE TO THE DISTAL AREA OF THE USER'S RIGHT RING FINGER WHICH WAAS REPLACED IN A MECHANISM CONTAINING MOVING PARTS.NOTE: USEER WAS SPECIFICALLY NOTIFIED OF CORRECT/SAFE OPERATING PROCEDURES DURING A PRIOR SERVICE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B.C.M. FILM CHANGER - CUT FILM IZP B.C. MEDICAL BCM-MS-600

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other