BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 6069008 · Received November 1, 2016

    Report

    Report Number
    9610902-2016-00017
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DENTIST INDICATED HE DELIBERATELY PUT THE DESENSITIZER ON THE PATIENT'S TISSUE. THIS IS OFF-LABEL USE. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PATIENT REPORTED THE RDH PUT GLUMA ON HER LOWER ANTERIORS SLIGHTLY TO LEFT OF CENTER. HE USED NO ISOLATION AND GLUMA GOT ON HER TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720065 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention