BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOND TOTAL ETCH

    MDR report key: 5633555 · Received May 5, 2016

    Report

    Report Number
    9610902-2016-00009
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    November 30, 2015
    Report Date
    April 19, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION. BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. EVALUATION SUMMARY, DIRECTIONS FOR USE STATE: CONTACT WITH SKIN OR MUCOUS MEMBRANES MAY CAUSE IRRITATION OR SENSITISATION. PREVENT CONTACT WITH SKIN, MUCOUS MEMBRANES AND EYES BY TAKING PRECAUTIONS SUCH AS A USING A DENTAL DAM (PATIENT), WEARING RUBBER GLOVES (DENTIST) AND WEARING SAFETY GLASSES (PATIENT, DENTIST). THE OFFICE FAILED TO MAINTAIN ISOLATION OF THE PREPARATORY PRODUCTS FOR THE APPLICATION OF IBOND TOTAL ETCH. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    PATIENT HAD FILLING DONE IN (B)(6) 2015, AT WHICH TIME ACID ETCH POSSIBLY GOT ON LOWER LIP, CAUSING BURNING SENSATION. NOTE: ACID ETCH USED WAS FROM A COMPETITOR, NOT HERAEUS KULZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290824 IBOND TOTAL ETCH AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other