BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 7503938 · Received May 10, 2018

    Report

    Report Number
    9610902-2018-00002
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    March 16, 2018
    Report Date
    April 23, 2018
    Manufacturer
    KULZER, LLC
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    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). BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THE INCIDENT IS BEING REPORTED TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    DENTIST CONTACTED MANUFACTURER'S INTERNATIONAL LAB INFO SITE, DESCRIBING ALLEGATION OF HARM FROM A PATIENT OF A COLLEAGUE. PATIENT HAD BURNT TISSUE AFTER GLUMA TREATMENT WHICH TOOK TWO WEEKS TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347569 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE KULZER, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other