BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 6785961 · Received August 10, 2017

    Report

    Report Number
    9610902-2017-00011
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    June 27, 2017
    Report Date
    June 28, 2017
    Manufacturer
    KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    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). 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 INADEQUATE.

    Description of Event or Problem · 0

    DENTIST APPLIED GLUMA DESENSITIZER OVER FEMALE PATIENT'S ENTIRE MOUTH, ALLOWING PATIENT TO CLOSE ON SUCTION AND NOT MAINTAINING ISOLATION FROM SOFT TISSUE,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566058 GLUMA DESENSITIZER POWERGEL VARNISH, CAVITY LBH KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other