BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TAPER WEDGE

    MDR report key: 1207775 · Received October 9, 2008

    Report

    Report Number
    2530191-2008-00005
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 8, 2008
    Manufacturer
    STELKAST, INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A BREACH WAS NOTICED IN THE TYVEK PACKAGING OF A DTW STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TAPER WEDGE LWJ STELKAST, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1