BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROBEX COMPACT

    MDR report key: 240532 · Received September 17, 1999

    Report

    Report Number
    2416455-1999-00001
    Event Type
    Injury
    Date Received
    September 17, 1999
    Date of Event
    August 11, 1999
    Report Date
    September 16, 1999
    Manufacturer
    COLTENE/WHALEDENT
    Product Code
    EKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    INCIDENT DATE: 08/11/1999. HAVING A PROBLEM WITH THE GROUND ON THIS MACHINE. A PT WAS SHOCKED AND BURNED INSIDE HER CHEEK. THE DR FEELS THE CAUSE WAS WATER SEEPING IN BETWEEN THE SLEEVE AND THE HEAD OF THE HANDPIECE WHICH HOLDS THE ELECTRODE TIP. IT HAPPENED TWICE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROBEX COMPACT Implant DENTIAL ELECTROSURGE EKZ COLTENE/WHALEDENT S300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other