BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA COMFORT BOND

    MDR report key: 3034903 · Received March 22, 2013

    Report

    Report Number
    9610902-2013-00039
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K992985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION NUMBER (B)(4), (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE ARE REPORTING IT TO BE COMPLAINT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE DIRECTIONS FOR USE STATES, "...APPLY A COPIOUS AMOUNT TO THE ENTIRE CAVITY SURFACE, APPLY TWO ADD'L COATS OF GLUMA COMFORT BOND AND WAIT FOR 15 SECONDS." THE DENTIST STATED THAT SHE ONLY USED TWO COATS OF GLUMA COMFORT BOND. THE USER FAILED TO FOLLOW THE INSTRUCTIONS. THESE FAILURES COULD LEAD TO MICROLEAKAGE OR BOND FAILURE WHICH MAY CAUSE THE PT TO EXPERIENCE SENSITIVITY. THE CAUSE OF THE COMPLAINT IS USER MISUSE. NO CAPA MEASURES ARE RECOMMENDED DUE TO THE AFOREMENTIONED MISUSE.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS FOR ONE DEVICE INVOLVED IN TWO EVENTS. DEALER REP WANTING CREDIT ON GLUMA COMFORT BOND BECAUSE PTS WERE HYPERSENSITIVE AFTER TREATMENT. SPOKE TO THE DENTIST. SHE SAID THAT THIS STARTED ABOUT 3 WEEKS AGO WHEN SHE STARTED USING THE GCB. "SHE SAID THAT THE ONLY THING SHE CHANGED." SHE SAID THAT SHE HAD TO CHANGE THE FILLINGS ON TWO OF THE PTS AND THEY ARE NOW BETTER. SHE SAID SHE USED THE OLD BONDING AGENT ON THEM. SHE SAID SHE USED RUBBER DAM ISOLATION, ETCHED, RINSED, DRIED, THEN APPLIED ONE COAT OF THE GCB AND DID A GENTLE AIR DRY, THEN APPLIED ANOTHER COAT AND DID ANOTHER GENTLE AIR DRY, THEN SHE CURED THE GCB. CONFIRMED THAT SHE ONLY USED TWO LAYERS AND SHE SAID THAT'S ALL SHE USES. DISCUSSED THAT THE DIRECTIONS CALLED FOR THREE LAYERS AND THAT TWO LAYERS MAY NOT BE ABLE TO PROVIDE ADEQUATE BOND STRENGTH AND THAT THIS MAY BE THE CAUSE OF THE SENSITIVITY AND WHY WE REQUIRED THREE LAYERS. SHE SAID THAT HER HUSBAND TOLD HER TO USE TWO LAYERS. SHE SAID SHE STILL HAD MORE GCB IN THE OFFICE AND SHE WOULD TRY THREE LAYERS. SHE SAID SHE DID NOT HAVE INDIVIDUAL EVENT INFO AVAILABLE. FOLLOW-UP CONTACT MADE, BUT OFFICE HAS NOT REPLIED TO MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119676 GLUMA COMFORT BOND KLE AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH 010211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention