BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2589726 · Received April 6, 2012

    Report

    Report Number
    9610902-2012-00004
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 26, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). THIS IS NOT A SERIOUS INJURY AS IT DOES NOT REQUIRE ANY MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. WE ARE GOING TO REPORT THIS EVENT TO THE (B)(4) DUE TO THE VERY SERIOUS FORESEEABLE MISUSE AND WRONG DIAGNOSIS. THEREFORE WE WILL REPORT IT TO THE FDA. THIS IS ADDRESSED IN THE DIRECTIONS FOR USE MUCOUS MEMBRANES ARE TO BE PROTECTED BY USING A RUBBER DAM AND TO BE SURE THAT GLUMA DESENSITIZER ONLY COMES INTO CONTACT WITH THE AREA TO BE TREATED. DIRECTIONS STATE TO RINSE GLUMA DESENSITIZER OFF THOROUGHLY WITH WATER AND APPLY SUCTION. USER FAILED TO PROPERLY ISOLATE TISSUE USING A RUBBER DAM AND RINSE GLUMA DESENSITIZER AFTER APPLICATION. THIS EXPOSED THE TISSUE TO THE GLUMA DESENSITIZER. IT IS ADDRESSED IN THE DIRECTIONS FOR USE THAT GLUMA DESENSITIZER IS IRRITATING TO SKIN AND CONTACT WITH SKIN SHOULD BE AVOIDED. IT IS STATED THAT IF NECESSARY PRECAUTIONS CANNOT BE TAKEN THEN GLUMA DESENSITIZER MUST NOT BE USED. THE PRODUCT HAS NOT BEEN EVALUATED AS THE USER FACILITY HAS NOT BEEN IDENTIFIED BY THE PATIENT REPORTER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, GLUMA DESENSITIZER WAS APPLIED GENEROUSLY BY THE DOCTOR'S ASSISTANT AND THE PATIENT IMMEDIATELY FELT A BURNING SENSATION WHEN THE MATERIAL GOT IN CONTACT WITH THE GINGIVA. NO RUBBER DAM WAS USED. THE PATIENT TOLD THE DOCTOR'S ASSISTANT ABOUT THE PAIN, BUT SHE EXPLAINED THAT THIS IS NORMAL. THE PATIENT WAS FORBIDDEN TO RINSE WITH WATER AND WAS ALLOWED NOTHING TO EAT OR DRINK FOR 1 HOUR. ON (B)(6) 2012, THE PATIENT HAD A SWOLLEN LIP FROM THE INSIDE AND THE WHOLE GINGIVAL LINE WAS WHITE COLORED. DUE TO PAIN SHE WENT TO THE HOSPITAL. A STRONG CAUTERIZATION OF THE GINGIVA WAS DIAGNOSED, BUT NO ADDITIONAL TREATMENT WAS GIVEN. PATIENT WAS CONTACTED ON (B)(4) 2012; SHE REPORTED EXPERIENCING TISSUE SLOUGHING AND PAIN HAS DECREASED. THE DENTIST DID NOT LOOK AT THE INJURY DESPITE THE PATIENT'S REQUEST HOWEVER HE DID DIAGNOSE AN ALLERGY REACTION DESPITE NOT OBSERVING THE PATIENT'S SYMPTOMS. THE PATIENT HAS EXPERIENCE WITH ALLERGIES AND DID NOT THINK THAT THESE SYMPTOMS WERE DUE TO AN ALLERGIC REACTION. THIS TYPE OF INJURY WOULD NOT NORMALLY BE REPORTED AS IT DOES NOT REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT INJURY. HOWEVER, WE ARE GOING TO REPORT THIS EVENT TO THE (B)(4) DUE TO THE VERY SERIOUS FORESEEABLE MISUSE AND WRONG DIAGNOSIS. THEREFORE, WE WILL REPORT IT TO THE FDA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other