BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 3727326 · Received April 4, 2014

    Report

    Report Number
    1925223-2014-00017
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 7, 2014
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTAL ASSISTANT

    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. 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. CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." THE ASSISTANT SAID THAT NO ONE WAS INJURED DURING THE INCIDENCE.

    Description of Event or Problem · 1

    (B)(4) DEALER EMAILED THE COMPLAINT AND OFFICE INFORMATION. CALLED AND SPOKE TO A DENTAL ASSISTANT IN THE OFFICE. THE CLAMP BROKE AS THEY WERE PLACING IT ON THE TOOTH. IT OCCURRED FEW MONTHS AGO. IT WOULD HAVE BEEN PLACED ON THE MOLAR. NO INJURIES OCCURRED, BUT IT WAS VERY STARTLING FOR THEM AND THE PATIENT WHEN IT BROKE. THIS WAS THE FIRST USE OF THE CLAMP. SHE SAID SHE DID NOT REMEMBER EXACTLY WHICH PATIENT THEY WERE TRYING TO USE IT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204596 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC 12A

    Patients

    Seq Age Sex Outcome Treatment
    1