BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDSWITCH

    MDR report key: 2851302 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03944
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE UNIVERSAL HANDSWITCH WAS SENT FOR EVAL BECAUSE IT WAS RUNNING ON SAFETY. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HANDSWITCH ERL STRYKER INSTRUMENTS KALAMAZOO 12125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK