BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KWIK BITE SENSO KODAK KITB

    MDR report key: 1251363 · Received December 5, 2008

    Report

    Report Number
    8031023-2008-00001
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Report Date
    November 9, 2008
    Manufacturer
    KERRHAWE SA
    Product Code
    EGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER BELIEVES THAT THE DOCTOR'S OFFICE IS NOT USING THE KWIK BITE HOLDERS CORRECTLY AND HAS ADVISED THE DOCTOR'S OFFICE THAT THE PATIENT SHOULD NOT BE BITING HARD ON THE MAIN BODY OF THE DEVICE. ACCORDING TO THE RISK ASSESSMENT OF THE PRODUCT, IT IS DEEMED UNLIKELY TO BREAK INTO SMALL PIECES. A TOTAL KITS HAVE BEEN SOLD ANNUALLY WORLDWIDE FOR MANY YEARS NOW WITHOUT ANY INCIDENT. THIS IS THE FIRST COMPLAINT THAT HAS EVER BEEN REPORTED ALLEGING THAT THE PRODUCT COULD CAUSE A SERIOUS INJURY IF THE PATIENT WERE TO SWALLOW A BROKEN PIECE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO THE DEALER THAT DURING NORMAL USE WHEN THE PATIENT BITES DOWN ON THE KWIK BITE X-RAY FILM HOLDER, IT HAS THE POTENTIAL TO BREAK INTO TWO PIECES EXPOSING THE SMALL INTERNAL COMPONENTS, WHICH IN HER OPINION COULD BE SWALLOWED BY THE PATIENT AND CAUSE A SERIOUS INJURY. NO INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWIK BITE SENSO KODAK KITB FILM, X-RAY HOLDER EGZ KERRHAWE SA 2700 KODAK

    Patients

    Seq Age Sex Outcome Treatment
    1