BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 3727328 · Received April 4, 2014

    Report

    Report Number
    1925223-2014-00018
    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
    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. NARRATIVE FOR RESULTS AND 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. CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE."

    Description of Event or Problem · 1

    (B)(6) DEALER EMAILED THE COMPLAINT AND OFFICE INFORMATION. THE OFFICE HAD COMPLAINED THAT IT BROKE WHILE IN USE. CALLED AND LEFT MESSAGES TO FOLLOW-UP WITHOUT RESPONSE FROM THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205109 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC W8A

    Patients

    Seq Age Sex Outcome Treatment
    1