BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2949603 · Received January 10, 2013

    Report

    Report Number
    1925223-2013-00022
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Report Date
    December 13, 2012
    Manufacturer
    HERAEUS KULZER, INC.
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    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 COMPLAINT 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

    DEALER REP IN (B)(4) EMAILED A CREDIT REQUEST. THE ONLY INFO PROVIDED IN THE E-MAIL WAS THAT IT WAS BROKE. A REQUEST WAS MADE TO THE DEALER REP FOR THE CUSTOMER CONTACT INFO SO FURTHER INFO CAN BE OBTAINED ON THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16048 IVORY CLAMP EEF CLAMP, RUBBER DAM EEF HERAEUS KULZER, INC. 13A REG MOLAR

    Patients

    Seq Age Sex Outcome Treatment
    1