BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOR WAND

    MDR report key: 2013451 · Received March 7, 2011

    Report

    Report Number
    MW5019687
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 28, 2011
    Manufacturer
    DEPUY MITEK INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MITEK VAPOR WAND ARCED WHEN THE DOCTOR USED IT. DOCTOR WAS PRESENT AND NO PROBLEMS WITH PATIENT REPORTED. WAND WAS A REPROCESSED WAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOR WAND VAPOR WAND GEI DEPUY MITEK INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR