BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 3173215 · Received June 5, 2013

    Report

    Report Number
    1925223-2013-00065
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 8, 2013
    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 CONCLUSION - DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "CAUTION: MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE OF THE CLAMP MAY CAUSE BREAKAGE."

    Description of Event or Problem · 1

    A (B)(4) DEALER REP EMAILED TO INQUIRE ABOUT A WARRANTY FOR THE CLAMPS BECAUSE AN OFFICE HAD A RECENTLY PURCHASED CLAMP BREAK. (B)(6) 2013, THE DEALER WAS NOTIFIED OF THE WARRANTY AND A REQUEST WAS MADE FOR DENTIST INFORMATION. THE DENTAL OFFICE COULD NOT BE CONTACTED DIRECTLY AS THEY ONLY SPEAK FRENCH. A QUESTIONNAIRE WAS SENT TO THEM TO GET INFORMATION ON THE CLAMP BREAKAGE. (B)(6) 2013, RECEIVED THE INCIDENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249414 IVORY CLAMP EEF CLAMP, RUBBER DAM EEF HERAEUS KULZER, LLC SS 12A REG MOLAR V2

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR