BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX SYSTEM MOTOR

    MDR report key: 602135 · Received July 1, 2004

    Report

    Report Number
    1045834-2004-00466
    Event Type
    Malfunction
    Date Received
    July 1, 2004
    Date of Event
    June 15, 2004
    Report Date
    June 25, 2004
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THE HOS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKMAX SYSTEM MOTOR MOTOR HBB THE ANSPACH EFFORT, INC. BLACKMAX-N A63005J

    Patients

    Seq Age Sex Outcome Treatment
    1 *