BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 8096346 · Received November 21, 2018

    Report

    Report Number
    9610902-2018-00005
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 20, 2018
    Manufacturer
    KULZER, GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF KULZER GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE ESTABLISHED THAT USER ERROR CAUSED THE INJURIES TO THE PATIENTS AND THE PATIENT DID NOT SEEK TREATMENT FROM A SECONDARY PROVIDER, AND ALL TISSUES HAVE HEALTHED WITHOUT PERMANENT DAMAGE, KULZER, LLC IS REPORTING THIS OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE (B)(6) REQUESTING THAT THIS BE REPORTED AND AT THE REQUEST OF OUR GLOBAL SAFETY OFFICER.

    Description of Event or Problem · 0

    INCIDENT OCCURED IN (B)(6). (B)(6) YO FEMALE. HYPOSALIVATION, SMOKER. PATIENT MEDICATIONS INCLUDE LAMICTAL AND SOMAC. AFTER TREATMENT WITH GLUMA DESENSITIZER POWERGEL, THE PATIENT HAD GINGIVAL INJURIES, HEADACHE, SKIN REACTION, BURNING FEELING, SWELLING/EDEMA. TREATING DDS APPLIED THE PRODUCT TO WHAT APPEARS TO BE MULTIPLE AREAS. THE DDS DID NOT USE ISOLATION, NOR DID THEY RINSE THE MATERIAL AFTER APPLICATION. THE PRODUCT WAS APPLIED AND THE PATIENT WAS ALLOWED TO LEAVE THE OFFICE WITH THE MATERIAL STILL ON THE TEETH. PER THE OFFICE ON (B)(6) 2018, THE PATIENT DID NOT SEEK SECONDARY TREATMENT AND THEY HAD BEEN SEEN BACK AT THE OFFICE FOR A FOLLOW UP VISIT AND THE PROVIDER WAS ABLE TO CONFIRM THAT THE INJURY HAS COMPLETELY HEALED WITHOUT PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934253 GLUMA DESENSITIZER POWERGEL DESENSITIZING AGENT KLE KULZER, GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other