BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL UNIVERSAL SMOKE EVAC ATTACHMENT

    MDR report key: 2417790 · Received January 12, 2012

    Report

    Report Number
    MW5023799
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 22, 2011
    Report Date
    January 2, 2012
    Manufacturer
    DEROYALINDUSTRIES
    Product Code
    FYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNIVERSAL SMOKE EVAC ATTACHMENT USED ON A BOVIE PENCIL. UPON CLEANING THE BOVIE TIP, THE CLEAR PLASTIC PROTECTOR ON THE EVAC SYSTEM POPPED OFF THE HAND HELD DEVICE. THE CLEAR PIECE POPPED OFF OF THE CRADLE WHERE IT ATTACHES TO THE DEVICE. THE CLEAR PLASTIC PROTECTOR WAS LOCATED OUTSIDE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL UNIVERSAL SMOKE EVAC ATTACHMENT SMOKE EVACUATOR ATTACHMENT FYD DEROYALINDUSTRIES 88-0006000 24420851

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR