BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALINE 600 U LATERAL FREE BEAM

    MDR report key: 11828 · Received March 3, 1994

    Report

    Report Number
    MW1000947
    Event Type
    Malfunction
    Date Received
    March 3, 1994
    Date of Event
    February 9, 1994
    Report Date
    March 1, 1994
    Manufacturer
    HERAEUS SURGICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USE, THE TIP WAS NOTED TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALINE 600 U LATERAL FREE BEAM GEX HERAEUS SURGICAL, INC. 3093U6

    Patients

    Seq Age Sex Outcome Treatment
    1 *