BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 6333102 · Received February 15, 2017

    Report

    Report Number
    9610902-2017-00002
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    January 24, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTAL HYGIENIST

    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. ISOLATION OF THE PATIENT'S SOFT TISSUE WAS NOT MAINTAINED. NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    (B)(6) CALLED TO REPORT A PATIENT COMPLAINING ABOUT HER ENTIRE MOUTH PEELING AND SORE. (B)(6) HAD PLACED GLUMA ON ENTIRE MOUTH FOR ONE MINUTE THE DAY BEFORE, NOT MAINTAINING ISOLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115778 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 Other