BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOND TOTAL ETCH

    MDR report key: 2970212 · Received February 13, 2013

    Report

    Report Number
    9610902-2013-00033
    Event Type
    Injury
    Date Received
    February 13, 2013
    Report Date
    January 17, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K083652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION # (B)(4), HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF AN ABUNDANCE CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. CONCLUSION - THE DIRECTIONS FOR USES STATES, "ALLOW IBOND TOTAL ETCH TO SET FOR 15 SECONDS." THE USER WAS NOT LETTING THE IBOND TE SET FOR 15 SECONDS AFTER APPLYING BEFORE MOVING TO THE AIR DRY STEP. OMITTING THIS STEP DOES NOT ALLOW THE DESENSITIZER TIME TO DESENSITIZE. THE OFFICE STATED THEY WERE CURING FOR 10 SECONDS WITH THE DEMIPLUS LIGHT BY KERR. THE IBOND TE DOES NOT ALLOW FOR REDUCTION OF CURE TIME IN THE DIRECTIONS FOR USE AND THAT THEY NEED TO FOLLOW THE 20 SECOND CURE TIMES FOR THAT REASON. THE IBOND TE MAY NOT HAVE COMPLETELY CURED AND THIS MAY HAVE CAUSED THE SENSITIVITY EXPERIENCED BY THE PATIENTS. THE USER FAILED TO FOLLOW THE INSTRUCTIONS FOR DWELL TIME AND CURE TIME. THESE FAILURES WOULD CAUSE THE SENSITIVITY EXPERIENCE BY THE PATIENTS. THE CAUSE OF THE COMPLAINT IS USER MISUSE. NO CAPA MEASURES ARE RECOMMENDED DUE TO THE AFOREMENTIONED USER ERROR/MISUSE.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF FIVE REPORTS FOR ONE DEVICE. ON (B)(6) 2013, HK SALES REP SENT THE FOLLOWING IN AN EMAIL: I HAVE A CUSTOMER HERE WHO GETS SENSITIVITY USING IBOND TOTAL ETCH WITH EVERY PATIENT. THEY CURE WITH THE KERR DEMIPLUS LIGHT FOR 10 SECONDS...DO YOU THINK THEY SHOULD BE CURING LONGER. COULD THAT BE THE ISSUE? CALLED THE OFFICE AND LEFT A MESSAGE ON THE ANSWERING MACHINE. ON (B)(4) 2013, SPOKE TO AN ASSISTANT AT THE OFFICE. SHE SAID THAT THEY HAVE HAD MANY PATIENTS THAT COMPLAINED OF SENSITIVITY AFTER IBOND TE WAS USED. THEY HAVE HAD TO REPLACE THE FILLINGS FOR 5 OF THE PATIENTS AS THE SENSITIVITY DID NOT DIMINISH. ASKED ABOUT THE PATIENTS. SHE SAID THAT ALL OF THE PATIENTS HAVE HAD THEIR FILLINGS REPLACED AND ARE DOING BETTER. SHE DID NOT WANT TO GIVE DETAILS ON THE INDIVIDUAL PATIENTS. ASKED ABOUT USAGE TECHNIQUE. SHE DESCRIBED TECHNIQUE. THEY WERE NOT LETTING THE IBOND TE SET FOR 15 SECONDS AFTER APPLYING, BEFORE MOVING TO THE AIR DRY STEP, AND THEY WERE CURING FOR 10 SECONDS WITH THE DEMIPLUS LIGHT BY KERR. ADVISED HER THAT THE IBOND TE DOES NOT ALLOW FOR REDUCTION OF CURE TIME IN THE DIRECTION FOR USE AND THAT THEY NEED TO FOLLOW THE 20 SECOND CURE TIMES FOR THAT REASON. ALSO DISCUSSED THAT THE IBOND TE NEEDS TO SET FOR 15 SECONDS BECAUSE THIS IS THE TIME THAT THE DESENSITIZING AGENT NEEDS TO WORK. SHE SAID SHE WOULD DISCUSS THIS WITH THE DENTIST. SHE GAVE THE LOT NUMBER 010046, BUT THIS IS NOT A VALID LOT NUMBER FOR THIS ITEM NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63713 IBOND TOTAL ETCH KLE AGENT, TOOTH BONDING RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention