BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BLADE

    MDR report key: 1911873 · Received November 23, 2010

    Report

    Report Number
    9616696-2010-00343
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT WAS USING A (B)(4) CAST CUTTER, IT IS UNK WHAT TYPE OF BLADE WAS BEING USED. ATTEMPTS TO COLLECT THIS INFO HAVE BEEN UNSUCCESSFUL. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NON-SEVERE BURNS TO PTS WHILE USING THE CAST CUTTER AND BLADE. ATTEMPTS TO COLLECT ADDITIONAL INFO FROM THE ACCOUNT HAVE BEEN UNSUCCESSFUL. THE ACCOUNT REPORTED THAT THEY ONLY WANTED THE MFR TO BE AWARE OF THE SITUATION AND THEY WERE NOT RETURNING THE DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BLADE SAW BLADES & ACCESSORIES HAB STRYKER INSTRUMENTS CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK