BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 6798034 · Received August 16, 2017

    Report

    Report Number
    9610902-2017-00012
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    July 24, 2017
    Manufacturer
    KULZER, LLC
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS OCCURRED IN GERMANY. AS ALLOWED BY EXEMPTION #E2012008, KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF KULZER, LLC (THE MANUFACTURER). THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION. BECAUSE THE ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED. STAFF FAILED TO MAINTAIN ADEQUATE ISOLATIONOF THE PATIENT'S SOFT TISSUE.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). GLUMA DESENSITIZER CAME IN CONTACT WITH MUCOSA. THE PATIENT COMPLAINED ABOUT MUCOSAL IRRITATION AND REDDENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578565 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE KULZER, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other