BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 3741239 · Received April 11, 2014

    Report

    Report Number
    1925223-2014-00019
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    HERAEUS KULZER, LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    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. THE DIRECTIONS FOR USE STATES, "CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." 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. " THE CLAMP USAGE EXCEEDED THE USE LIFE OF ONE YEAR WHICH IS STATED AS THE USE LIFE IN THE DIRECTIONS FOR USE. NOT RETURNED/NO LOT INFO.

    Description of Event or Problem · 1

    (B)(6) 2014 RECEIVED FORWARDED EMAIL FROM A (B)(6) DEALER WITH THE FOLLOWING INFORMATION WITHIN IT: A DENTIST BOUGHT A CLAMP 12A ON (B)(6) 2012. IF YOU LOOK INVOICE COPY. IT'S BROKEN IN 2 PARTS. REQUEST THAT THE HK REP RETURN THE CLAMP FOR EVALUATION AND INFORMED THAT THE CLAMP WAS OUT OF WARRANTY. HK REP HAS TRIED TO RETRIEVE THE CLAMP FROM THE DEALER, BUT IT HAS NOT BEEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224525 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1