BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2632835 · Received June 22, 2012

    Report

    Report Number
    1925223-2012-00048
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Report Date
    June 6, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING ON SECOND 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." THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DR (B)(6) SENT ANOTHER EMAIL IN RESPONSE TO THE USAGE QUESTIONS THAT WERE SENT TO HIM ABOUT ANOTHER CLAMP. DR (B)(6) WROTE: I WASN'T SURE IF THERE WERE 1 OR 2 STUDENTS WHO HAD AN INCIDENT WITH THEIR CLAMP. HERE ARE THE ANSWERS OF THE OTHER STUDENT. I'M ALMOST SURE WE DON'T HAVE THIS SECOND CLAMP AVAILABLE, SORRY. UNIV IS NOW FINISHED AND EVERYONE IS BACK HOME ALL OVER THE PROVINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC #SS 4 REG MOLAR

    Patients

    Seq Age Sex Outcome Treatment
    1