BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2565583 · Received April 27, 2012

    Report

    Report Number
    1925223-2012-00011
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 27, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GENERALLY BROKEN CLAMPS HAVE NOT BEEN REPORT BUT AS THE ASSISTANT ALLEGES THAT, "THE OTHER PIECE FLEW ACROSS THE ROOM. SHE SAID THAT THE PT WAS UPSET AS IT SOUND AS IF YOUR TOOTH IS BREAKING." IT IS FOR THIS REASON THAT IT IS RECOMMENDED THAT THE INCIDENCES BE REPORTED. THE ASSISTANT HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES. METHOD - THE RECEIVED 1 CLAMP LOT P1, MFR DATE 11/2011. CLAMP IS BROKEN ON THE BOW. FROM THE TOP THE BREAK IS BETWEEN THE "C" AND "E" IN THE "CE" MARK. FROM THE BOTTOM THE BREAK IS ON THE "1" IN "P1." BATCH RECORDS INDICATE NO ABERRATIONS. THE DIRECTIONS FOR USE STATES THAT THE RUBBER DAM CLAMP SHOULD BE LIGATED TO THE FRAME AND THE RUBBER DAM ASSEMBLY PLACED BEFORE THE CLAMP IS PLACED ON THE TOOTH. THIS WOULD PRECLUDE CHOKING AND ASPIRATING HAZARDS FROM DEVICE BREAKAGE. ALSO, DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE AS THIS CAN OCCUR DUE TO MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF 2 COMPLAINTS FROM ONE OFFICE ON 2 SEPARATE EVENTS FOR 2 DIFFERENT CLAMPS. ON (B)(4) 2012, (B)(4) CALLED AND SAID HE PICKED UP A CLAMP FROM DR (B)(6) OFFICE THAT BROKE. HE DID NOT KNOW ANY FURTHER INFO. HE IS SENDING THE CLAMP IN FOR EVAL. I CALLED OFFICE AND SPOKE TO (B)(6). SHE SAID SHE WAS GLAD I CALLED AS IT HAPPENED AGAIN. I ASKED IF SHE HAD THE CLAMP SO THAT I COULD GET THE BATCH NUMBER. SHE SAID SHE THREW THE CLAMP AWAY. SHE SAID THEY GOT BOTH OF THE CLAMPS IN THE SAME ORDER. SHE SAID THAT THE EVENT IS RATHER STARTLING. I ASKED HER TO DESCRIBE EACH EVENT. EVENT (B)(6) 2012 PT FEMALE (B)(6). SHE HAD THE RUBBER DAM IN PLACE AND LIGATED ONE SIDE OF THE CLAMP. SHE WAS PLACING THE CLAMP ONTO TOOTH #3 WHEN IT BROKE. SHE SAID THAT THE SIDE THAT WAS LIGATED FELL INTO THE PT'S LAP AND THE OTHER PIECE FLEW ACROSS THE ROOM. SHE SAID THAT THE PT WAS UPSET AS IT SOUND AS IF YOUR TOOTH IS BREAKING. SHE SAID THAT THE PT WAS VERY STARTLED AND SHE WAS TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 12A P1

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR