BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-CHOICE OWENS AND MINOR

    MDR report key: 1032234 · Received April 18, 2008

    Report

    Report Number
    1030322-2008-00003
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 8, 2008
    Report Date
    April 18, 2008
    Manufacturer
    BOVIE MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K94576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFO AND/OR THE PRODUCT FOR INSPECTION FROM THE INITIAL REPORTER HAVE BEEN UNSUCCESSFUL AS PHONE CALLS AND E-MAILS HAVE NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A FIRE OCCURRED IN A SHARPS DISPOSAL CONTAINER AFTER CAUTERY DISPOSAL. THE CAUTERY WAS DISPOSED OF CORRECTLY PER PHONE CONVERSATION WITH THE REPORTER. THE TIP WAS REMOVED PER INSTRUCTIONS ON THE COVER CAP. THE COVER CAP WAS REAPPLIED AND DISPOSED OF IN A BIOHAZARD CONTAINER. PER FIRE INVESTIGATION RESULTS: SOMETHING JARRED THE CAUTERY CAUSING THE DEVICE TO SMOLDER ALL WEEKEND. PERSONNEL DISCOVERED THE SMOKE ALARMS HAD EXTINGUISHED THE FIRE. THERE WERE NO INJURIES. FIRE INSPECTORS REMOVED ALL PRODUCT INVOLVED IN THE FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-CHOICE OWENS AND MINOR CAUTERY GEI BOVIE MEDICAL 0606-5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK