BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER (DEVICE 2)

    MDR report key: 2740525 · Received August 30, 2012

    Report

    Report Number
    9610902-2012-00129
    Event Type
    Injury
    Date Received
    August 30, 2012
    Report Date
    August 3, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION #(B)(4), (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (THE MFR). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. WE CANNOT RULE OUT CAUSALITY. CONCLUSION CODE, THE OFFICE STATED THEY, "APPLY THE GLUMA DESENSITIZER THEN BLOW IT OFF," AND THE DIRECTIONS FOR USE STATES, "LEAVE (GD) FOR 30-60 SECONDS. THEN DRY THE SURFACE CAREFULLY BY APPLYING A STREAM OF COMPRESSED AIR UNTIL THE FLUID FILM HAS DISAPPEARED AND THE SURFACE IS NO LONGER SHINY. THEN RINSE THOROUGHLY WITH WATER." THE OFFICE DID NOT FOLLOW THE DIRECTIONS WHEN USING THE GLUMA COMFORT BOND. EFFICACY CANNOT BE GUARANTEED WHEN THE DIRECTIONS ARE NOT FOLLOWED. THIS PRODUCT WAS NOT THE FOCUS OF THE COMPLAINT IT WAS ONLY MENTIONED AS BEING USED DURING THE OFFICES RESTORATIVE PROCESS AND WAS REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    RECEIVED COMPLAINT THAT OFFICE HAD RESTORATIONS COME OUT ON UP TO 12 PTS. THEY REPORTED USING 2 HERAEUS PRODUCTS DURING THE RESTORATIVE PROCEDURE. THEY HAD TREATMENT INFO ON 6 OF THE PTS. THIS IS THE THIRTEENTH OF 14 REPORTS FOR DEVICE 2. ON (B)(4) 2012, DEALER REP CALLED TO RETURN THE GLUMA COMFORT BOND (GCB) BECAUSE HE SAID IT IS NOT BONDING PROPERLY. A MESSAGE WAS LEFT AT THE OFFICE TO FIND OUT WHAT NOT WORKING PROPERLY MEANT. ON (B)(4) 2012, A DENTAL ASSISTANT WAS CONTACTED AT THE OFFICE. SHE REPORTED THAT OVER THE LAST COUPLE OF MONTHS, THEY HAVE NOTICED ABOUT 10 OR 15 FILLINGS THAT HAVE POPPED OUT FROM THE ANTERIOR AND POSTERIOR AS WELL. SHE SAID THEY ETCH, RINSE, AND DRY. APPLY GLUMA DESENSITIZER AND BLOW IT OFF. THEY APPLY ONE COAT OF GCB, AIR DRY, LIGHT CURE FOR 10 SECONDS AND REPEAT. THEY USE PATTERSON BRAND FLOWABLE AND TETRIC CERAM COMPOSITE BY IVOCLAR. I EXPLAINED THAT WE RECOMMEND THE GLUMA DESENSITIZER BE USED WITH A RUBBER DAM, LEFT ON FOR 30-60 SECONDS AND RINSED UNDER SUCTION. THE GCB IS TO BE PLACED IN THREE COATS, LEFT TO DWELL FOR 15 SECONDS, APPLY LIGHT AIR FLOW TO EVAPORATE THE SOLVENT AND LIGHT CURED FOR 20 SECONDS. THEN SPOKE TO ANOTHER ASSISTANT. SHE WAS ASKED IF SHE KNEW WHICH PTS WERE INVOLVED. SHE SAID SHE DID. REQUESTED TO KNOW THE PTS, TREATMENT AREAS, TREATMENT DATES, AND DATES PT REPORTED DEBONDING TO THE OFFICE. SHE SAID SHE WOULD GET THIS INFO AND CALL BACK TOMORROW. ON (B)(4) 2012, SPOKE TO THE SECOND ASSISTANT. SHE SAID THAT SHE REMEMBERED SIX OF THE PTS AND BELIEVES THERE MAY BE 2 TO 6 MORE. ON PT #11, THEY DID NOT REMEMBER THE PT AND DID NOT GIVE DETAILS OF THE TREATMENT. ON (B)(4) 2012, SPOKE TO THE FIRST ASSISTANT. ASKED HOW THE PTS WERE DOING. SHE SAID THEY WERE FINE AND THE FILLINGS DID NOT COME OUT. SHE SAID THEY DID NOT USE THE GCB TO BOND THE REPLACEMENT FILLINGS SHE SAID THAT THEY USED FUTURA BOND BY VOCO AND THAT THEY HAVE SWITCHED. I ASKED IF THE DENTIST HAS TRIED THE REPLACEMENT GCG THAT WAS SENT. SHE SAID HE HAS NOT. SHE SAID THAT THEY HAVE BEEN CONTACTED 3 TIMES ABOUT THIS AND ASKED WHY. I TOLD THAT WE LIKE TO F/U ON THE PT STATUS. SHE SAID THAT WAS NICE, BUT THAT THEY DID NOT WANT TO BE CONTACTED ANYMORE ABOUT THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER (DEVICE 2) KLE AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention