BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 6671182 · Received June 27, 2017

    Report

    Report Number
    9610902-2017-00010
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 14, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    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, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION. BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THIS INCIDENT IS BEING 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 ISOLATION OF THE PATIENT'S SOFT TISSUE. H3 OTHER TEXT : PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). CHILD COMPLAINED OF UNPLEASANT SENSATION AND BURNING THROAT AFTER TREATMENT WITH GLUMA DESENSITIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450646 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other