BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 7618666 · Received June 20, 2018

    Report

    Report Number
    9610902-2018-00003
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    May 30, 2018
    Report Date
    May 30, 2018
    Manufacturer
    KULZER, LLC
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    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. DIRECTIONS FOR USE INDICATE THAT ISOLATION MUST BE MAINTAINED IN ORDER TO PROTECT THE SOFT TISSUE. ISOLATION WAS NOT MAINTAINED.

    Description of Event or Problem · 0

    A (B)(6) FEMALE PATIENT HAD GLUMA APPLIED 6 TIMES WITHOUT USE OF ISOLATION OR RINSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460875 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE KULZER, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other