BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2949492 · Received February 1, 2012

    Report

    Report Number
    9610902-2013-00025
    Event Type
    Other
    Date Received
    February 1, 2012
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION #(B)(4), (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE MFR). 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 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 DIRECTIONS ALSO STATE, "GLUMA DESENSITIZER MUST NOT BE USED IF THE PT IS ALLERGIC TO ANY INGREDIENTS CONTAINED IN GLUMA DESENSITIZER." THE GLUMA DESENSITIZER WAS EXPIRED AT THE TIME OF USE. (B)(4) DOES NOT RECOMMEND THE USE OF OUR PRODUCTS AFTER THE EXPIRY DATE.

    Description of Event or Problem · 1

    THE PT'S PHARMACIST CALLED BECAUSE A CUSTOMER REPORTED TO HIM THAT HE HAD AN ALLERGIC REACTION TO GLUMA. HE WANTED TO KNOW IF WE HAD TREATMENT RECOMMENDATIONS AND THOUGHT WE SHOULD BE NOTIFIED. HE DID NOT KNOW THE DENTAL OFFICE NAME OR ANY OTHER INFO. HE SAID HE WOULD HAVE THE PT CALL. THE PT CALLED AND SAID THAT THE HYGIENIST APPLIED THE GLUMA TO THE AREA. HE SAID THAT THE LOWER LIP IMMEDIATELY STARTED TO BURN AND WITHIN A MINUTE THE PUCKERING AND SWELLING BEGAN. HE SAID HE HAS HAD ALLERGIC REACTIONS BEFORE AND THIS WAS LIKE THAT. HE SAID THAT THE SWELLING IS STARTING TO DIMINISH TODAY, BUT THE AREA IS RED AND THERE IS A LARGE BLISTER. HE SAID THAT HE HAS BEEN RINSING THE AREA AND USING VITAMIN A AND D OINTMENT. ADVISED HIM TO SEE HIS PHYSICIAN OR AN ALLERGIST. HE SAID THAT HE IS AN (B)(6) PATIENT AND REGULARLY SEES A PHYSICIAN. HE SAID HE WOULD CALL THE OFFICE TO GET A REFERRAL TO AN ALLERGIST AND HAVE THE DOCTOR LOOK AT IT TOO. HE SAID HE WOULD CALL THE DENTIST TO LET HER KNOW HE HAD SPOKEN TO ME. HE SAID THAT SHE WOULD PROBABLY NOT SPEAK TO ME UNLESS HE CALLED HER FIRST. ON (B)(6) 2012, THE PT CALLED BACK AND STATED THAT HE HAS SCHEDULED AN ALLERGY TEST FOR 01/28/2013. HE SAID THAT THE AREA COMPLETELY HEALED WITHIN 3 DAYS. THAT THE SWELLING WAS GONE ABOUT 24 HRS AFTER TREATMENT AND THAT THE TISSUE JUST PEELED OFF. HE SAID HE DID NOT TAKE AN ALLERGY MEDICATION OR USE ANYTHING BESIDES THE OINTMENT SINCE THE SYMPTOMS STARTED TO RESOLVE WITHIN 25 HOURS. HE SAID HE IS PURSUING THE ALLERGY TESTING AS HE THINKS THIS MAY HAVE BEEN AN INITIAL REACTION AND DOES NOT WANT TO RISK EXPOSURE IF HE HAS AN ALLERGY. PT SAID HE WOULD CALL BACK WITH THE TEST RESULTS. ON (B)(6) 2013, THE DENTIST CALLED. ASKED IF ANY FROM THE BOX ARE STILL AVAILABLE. SHE SAID THAT THEY THREW THE REST OF THE BOX AWAY AFTER THIS HAPPENED BECAUSE THE EXPIRATION ON THE BOX WAS 01/2013. INFORMED THAT THE EXPIRY DATE IS THE FIRST OF THE MONTH. SHE SAID THAT THIS MEANT THEY USED EXPIRED MATERIALS. ASKED WHERE THE TREATMENT WAS. SHE SAID LOWER ANTERIOR FACIALS. ASKED FOR THE ISOLATION METHOD USE. SHE SAID COTTON ROLL. SHE SAID THAT AS SOON AS IT WAS APPLIED, HE PULLED HIS LIP IN AND SAID IT BURNED THUS INCREASING THE AREA THE GLUMA CONTACTED. ADVISED THAT WE RECOMMEND RUBBER DAM ISOLATION IN THE DIRECTIONS. ASKED TO DESCRIBE THE TISSUE AFTER EXPOSURE. SHE SAID THAT THE TISSUE IMMEDIATELY BECAME RED AND INFLAMED. SHE SAID THAT ABOUT TEN MINUTES AFTER THE EXPOSURE THE AREA BECAME WHITE AND DESICCATED IN APPEARANCE. SHE SAID THAT THE TISSUE LATER SLOUGHED OFF AND HE WAS BETTER IN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 010200

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other