BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA COMFORT OND + DESENSITIZER

    MDR report key: 3127367 · Received May 6, 2013

    Report

    Report Number
    9610902-2013-00045
    Event Type
    Injury
    Date Received
    May 6, 2013
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    KLE
    PMA / PMN Number
    K992292
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION # (B)(4), (B)(6) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE ARE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. USER DID NOT USE PER DFU. CONCLUSIONS: THE DIRECTIONS FOR USE STATES, "APPLY A COPIOUS AMOUNT TO THE ENTIRE CAVITY SURFACE. APPLY TWO ADDITIONAL COATS OF GLUMA COMFORT BOND + DESENSITIZER AND WAIT FOR 15 SECONDS." THE DENTIST STATES, SHE CURED BETWEEN LAYERS. THE LAYERING WITHOUT CURING AND SUBSEQUENT 15 SECOND DWELL TIME ALLOWS THE GCB&D THE TIME REQUIRED TO DESENSITIZE. NOT FOLLOWING THESE STEPS WOULD NOT ALLOW ENOUGH TIME FOR THE DESENSITIZER TO WORK. THE DIRECTIONS FOR USE ALSO STATED, "GLUMA COMFORT BOND + DESENSITIZER CONTAINS ETHANOL. USE A GENTLE AIR BLAST TO EVAPORATE SOLVENT AND WATER." THE DENTIST DID NOT DO THIS STEP. NOT EVAPORATING THE SOLVENT PRIOR TO CURING CAN CAUSE INADEQUATE CURING OF THE BONDING AGENT WHICH CAN CAUSE HYPERSENSITIVITY. THIS COMPLAINT CANNOT BE CONFIRMED DUE TO USER ERROR AS THE USER FAILED TO FOLLOW THE METHOD DESCRIBED IN THE DIRECTIONS FOR PROPER USAGE. NO OTHER PRODUCT QUALITY COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER. DUE TO THE AFOREMENTIONED REASONS, CAPA MEASURES ARE NOT RECOMMENDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197910 GLUMA COMFORT OND + DESENSITIZER KLE AGENT, TOOTH BONDING RESIN KLE HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1