BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 3001142 · Received March 6, 2013

    Report

    Report Number
    9610902-2013-00036
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), HERAEUS (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE OUT OF AN ABUNDANCE CAUTION TO BE COMPLIANT WITH 21 CFR. CONCLUSION CODE- THE DIRECTION FOR USE HAS ADEQUATE WARNING AGAINST EXPOSURE STATING, "IRRITATING TO SKIN. THE PRODUCT CONTAINS (B)(4) THAT MAY CAUSE SENSITIZATION BY SKIN CONTACT. GLUMA DESENSITIZER POWERGEL CONTAINS (B)(4) THAT MAY CAUSE LOCALIZED IRRITATION AND MAY CAUSE SENSITIZATION EITHER DIRECTLY OR THROUGH INHALATION. AVOID CONTACT WITH SKIN, IMMEDIATELY WASH WITH PLENTY OF WATER AND SOAP. CONCLUSION: THE DIRECTIONS FOR USE STATES, "PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM. APPLY SMALLEST AMOUNT POSSIBLE AND LEAVE FOR 30-60 SECONDS. RINSE WITH PLENTY OF WATER AND APPLY SUCTION." THE TYPE OF ISOLATION WAS NOT INDICATED IN THE REPORT, HOWEVER THE USE OF RUBBER DAM ISOLATION WOULD PRECLUDE MUCOSAL EXPOSURE AS HARD TISSUE (TOOTH) TREATMENT AREA WOULD BE THE ONLY AREA EXPOSED AND THE ORAL ENVIRONMENT IS ISOLATED UNDER A RUBBER SHEET. THE OFFICE REPORTED NOT RINSING THE GLUMA DESENSITIZER POWERGEL AFTER TREATMENT AND THEREFORE THE PATIENT WOULD HAVE BEEN RELEASED FROM THE OFFICE WITH THE GEL STILL ON THE TEETH. THIS WOULD HAVE LEFT THE GEL ON THE TEETH BEYOND THE RECOMMENDED 30-60 SECONDS. DIRECTIONS FOR USE STATES, "GLUMA DESENSITIZER POWERGEL MUST NOT BE USED IF NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION TECHNIQUE IS NOT POSSIBLE."

    Description of Event or Problem · 1

    TWO DAYS AFTER APPLICATION, THE PATIENT HAD AN INFLAMMATION ON THE GUM. IT BECAME AN ULCER. THE STAFF, NOT A DENTIST, APPLIED GLUMA TO THE PATIENT. RINSING WAS NOT BEEN DONE. THE PATIENT WAS PRESCRIBED TETRACYCLINE OINTMENT AND STEROID OINTMENT. THE SYMPTOMS WERE IMPROVED SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96061 GLUMA DESENSITIZER POWERGEL LBH VARNISH, CAVITY LBH HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention