BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLACKMAX SYSTEM MOTOR

    MDR report key: 598281 · Received June 18, 2004

    Report

    Report Number
    1045834-2004-00450
    Event Type
    Other
    Date Received
    June 18, 2004
    Date of Event
    May 21, 2004
    Report Date
    June 7, 2004
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REQUESTED THE EVALUATION OF THE MOTOR DUE TO IT HAVING BEEN USED IN A PROCEDURE WITH A PERFORATOR THAT CAUSED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKMAX SYSTEM MOTOR MOTOR HBB THE ANSPACH EFFORT, INC. BLACKMAX-N 13710C

    Patients

    Seq Age Sex Outcome Treatment
    1 *