BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL PUSH BUTTON PENCIL W/ENT

    MDR report key: 1932158 · Received December 3, 2010

    Report

    Report Number
    9613793-2010-00002
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WAS REQUESTED REGARDING THE REPORTED PT INTERACTION WITH THE ELECTRO-CAUTERY PENCIL AND THAT HAS NOT BEEN RECEIVED AS OF THIS REPORT DATE. THE INCIDENT DEVICE REPORTED TO HAVE SPARKED WAS NOT RETURNED FOR INSPECTION. A RANDOM INSPECTION AND REVIEW OF CAUTERY PENCILS ON HAND WITH MFG WAS PERFORMED AND NO ISSUES OF SPARKING OCCURRED. A DEFINITIVE ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED WITH THE INFO PROVIDED.

    Description of Event or Problem · 1

    THE HOSPITAL STATES, THE DEVICE IS SPARKING INSIDE THE PT'S MOUTH AT TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL PUSH BUTTON PENCIL W/ENT CAUTERY PENCIL GEI DEROYAL INDUSTRIES, INC. 19961653

    Patients

    Seq Age Sex Outcome Treatment
    1