BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2598410 · Received May 29, 2012

    Report

    Report Number
    1925223-2012-00019
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Report Date
    May 25, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING ON FIRST USE, THE CLAMP MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. 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

    ON (B)(6) 2012, (B)(6) REPORTED THAT HE HAS A CLAMP THAT WAS RETURNED FOR CREDIT ON NSP # (B)(4) BECAUSE IT BROKE ON THE FIRST USE. ON (B)(6) 2012, CALLED THE OFFICE. THE VOICE MESSAGE SAID THAT THEY WOULD BE CLOSED UNTIL (B)(6) 2012. I LEFT A MESSAGE THAT I CALLED CONCERNING THE CLAMP THAT BROKE ON FIRST USE AND ASKED THAT THEY CALL BACK. I LEFT MY CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS W4 WNGLSS MOLAR P1

    Patients

    Seq Age Sex Outcome Treatment
    1