BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2588809 · Received May 14, 2012

    Report

    Report Number
    1925223-2012-00016
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    GENERALLY BROKEN CLAMPS HAVE NOT BEEN REPORTED BUT AS THE DENTIST WAS VERY WORRIED ABOUT THE POSSIBILITY FOR THE PT TO SWALLOW THE FRAGMENTS. IT IS FOR THIS REASON THAT IT IS RECOMMENDED THAT THE INCIDENCES BE REPORTED. THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES. THE CLAMP IS IN (B)(4) AND WE ARE STILL AWAITING ITS RETURN FOR INSPECTION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO COMPLAINTS FROM ONE (B)(6) OFFICE ON TWO SEPARATE EVENTS FOR TWO DIFFERENT CLAMPS. A DENTIST HAS WRITTEN TO US COMPLAINING ABOUT TWO DIFFERENT CLAMPS WITH TWO PTS. THE CLAMPS WERE UNEXPECTEDLY BROKEN DURING POSITIONING. THE DENTIST WAS VERY WORRIED ABOUT THE POSSIBILITY FOR THE PT TO SWALLOW THE FRAGMENTS. IN THE SECOND CASE, THE DOCTOR DOESN'T REMEMBER THE TOOTH, BECAUSE HE DIDN'T WRITE DOWN ANY INFO EXCEPT THE CLAMP BREAK. THIS BROKE BEFORE THE POSITIONING ON THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 2A

    Patients

    Seq Age Sex Outcome Treatment
    1