BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 4173266 · Received October 15, 2014

    Report

    Report Number
    1925223-2014-00066
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    HERAEUS KULZER, LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION." CONCLUSION - DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "DO NOT PLACE CLAMP IN MOUTH UNTIL THE RUBBER DAM HAS BEEN PROPERLY PLACED. CLAMP COULD BECOME A CHOKING OR SAFETY HAZARD IF DROPPED OR BROKEN IN THE MOUTH WITHOUT PROPER USE OF THE RUBBER DAM AT ALL TIMES."

    Description of Event or Problem · 1

    REPORTED BY (B)(6): IVORY CLAMP SS W7 WNGLSS MOLAR SNAPPED AT (B)(6). NO FURTHER INFORMATION WAS PROVIDED. THIS CLAMP BREAKAGE OCCURRED IN (B)(6). THIS MALFUNCTION IS REPORTABLE AS SEC 803.50 STATES: IF YOU ARE A MANUFACTURER, YOU MUST REPORT TO US NO LATER THAN 30 CALENDAR DAYS AFTER THE DAY THAT YOU RECEIVE OR OTHERWISE BECOME AWARE OF INFORMATION, FROM ANY SOURCE, THAT REASONABLY SUGGESTS THAT A DEVICE YOU MARKET HAS MALFUNCTIONED AND THIS DEVICE OR A SIMILAR DEVICE THAT YOU MARKET WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654469 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER, LLC IVORY CLAMP SS W7 WNGLSS MOLAR L1

    Patients

    Seq Age Sex Outcome Treatment
    1