BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2600877 · Received May 16, 2012

    Report

    Report Number
    9610902-2012-00010
    Event Type
    Other
    Date Received
    May 16, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 15, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). NARRATIVE FOR 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 DUE TO THE VERY SERIOUS FORESEEABLE MISUSE AND WRONG DIAGNOSIS. EVAL SUMMARY: CONCLUSION - 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 DID NOT RINSE GLUMA DESENSITIZER AS DESCRIBED IN THE DIRECTIONS FOR USE. 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 DENTIST PRESCRIBED AN ANTIALLERGENIC ALTHOUGH THE SYMPTOMS APPEAR TO BE MORE CONSISTENT WITH A CHEMICAL BURN WHICH COULD HAVE BEEN PREVENTED HAD PROPER TISSUE ISOLATION BEEN USED BY THE DENTIST. DIRECTIONS FOR USE WARNS, "THIS PRODUCT OR ONE OF ITS COMPONENTS MAY IN PARTICULAR CASES CAUSE HYPERSENSITIVITY REACTIONS." THE DEVICE HAS BEEN SENT TO THE MFR FOR COMPOSITION TESTING AS THE OFFICE ALLEGES THAT IT HAS AN ABNORMAL ODOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AN ASSISTANT FROM DR (B)(6)'S OFFICE SAID A PT HAD A REACTION TO GLUMA DESENSITIZER. THE ASSISTANT SAID THAT THE PT DOES NOT HAVE ANY KNOWN ALLERGIES, BUT HAS HAD A REACTION TO EPINEPHRINE ONCE. THE PT CAME IN FOR DELIVERY OF A RETAINER AND MENTIONED HER LOWER FRONT TEETH WERE SENSITIVE TO HOT AND COLD. THE ASSISTANT SAID THE DIAGNOSIS WAS CERVICAL EROSION. THEY APPLIED THE GLUMA DESENSITIZER ON HER AT LEAST ONE OTHER OCCASION WITH NO INCIDENT. I ASKED HOW THE PRODUCT WAS APPLIED AND HE SAID THE ASSISTANT PLACED 4 APPLICATIONS ON ALL SURFACES OF TEETH #21 TO 28 (INCISAL, LINGUAL, AND LABIAL.) HE SAID SOME OF THE GLUMA DESENSITIZER CAME INTO CONTACT WITH THE TISSUE ON THE LINGUAL AND THE PT COMPLAINED OF A BURNING SENSATION AND UNUSUAL SMELL. I ASKED IF THEY USED A RUBBER DAM AND HE REPLIED NO. THEY HAD THE PT RINSE WITH WATER. I ASKED IF THEY GAVE HER WATER FROM THE AIR/WATER SYRINGE AND HAD HER SWISH AND SPIT. HE REPLIED YES. THE ASSISTANT THEN TOOK 2 X 2 GAUZE SQUARE AND WIPED THE LINGUAL OF THE MANDIBULAR ARCH. HE SAID THE PT'S GINGIVAL TISSUE CAME OFF ONTO THE GAUZE SQUARE. HE SAID HER GINGIVA WAS MORE RED THAN NORMAL AND STIPPLED, NO BLEEDING. THE DOCTOR SMELLED THE GLUMA DESENSITIZER AND HE SAID IT SMELLED DIFFERENT THAN NORMAL. I ASKED IF HE WOULD LIKE A COPY OF THE DIRECTIONS FOR USE AND THE MSDS. HE SAID NO, THEY HAVE BOTH ON FILE. I WENT OVER THE DIRECTIONS FOR USE WITH HIM OVER THE PHONE. I SAID WE RECOMMEND THE USE OF A RUBBER DAM AS THE MATERIAL IS NOT TO BE USED OR ALLOW TO DRIP ONTO SOFT TISSUE. I EXPLAINED WE RECOMMEND ONLY ONE APPLICATION OF THE PRODUCT USING THE SMALLEST AMOUNT OF MATERIAL NEEDED. ALLOW THIS TO SIT FOR 30-60 SECONDS AND RINSE UNDER HVE SUCTION. HE THEN ASKED IF THE PRODUCT IS SUPPOSED TO BE LIGHT CURED. I VERIFIED THE PRODUCT WAS ACTUALLY GLUMA DESENSITIZER AND EXPLAINED THE PRODUCT IS NOT A LIGHT CURED MATERIAL. I ASKED IF THE PT SAW HER MEDICAL DOCTOR AND HE SAID HE DOES NOT THINK SO. I ASKED IF THE DENTIST PRESCRIBED ANY MEDICATION FOR THE PT AND HE SAID NO, THEY RECOMMENDED SHE KEEP VASELINE ON THE AREA. THE PT IS COMING IN (B)(6) 2012 AT 3:00 PM PST FOR AN EVAL. I ASKED IF I COULD CALL BACK ON TO F/U ON THE PT'S CONDITION. HE SAID I COULD. ON (B)(6) 2012, I SPOKE TO THE ASSISTANT TO F/U ON THE PT AND HE SAID THE DENTIST DID CALL IN A PRESCRIPTION FOR KENALOG IN ORABASE ON (B)(6) 2012. HE SAID SHE WAS MUCH IMPROVED ON THE (B)(6) 2012 F/U APPOINTMENT. NO REDNESS OR STIPPLING. THE PT DID NOT SEE A MEDICAL DOCTOR. THE DENTIST DID NOT PRESCRIBE ANY MEDICATIONS ON THE F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 010205

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other