BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 6536609 · Received May 2, 2017

    Report

    Report Number
    9610902-2017-00007
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 12, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS OCCURRED IN SWITZERLAND. 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 DID NOT MAINTAIN ADEQUATE ISOLATION.

    Description of Event or Problem · 0

    PATIENT COMPLAINED OF IRRITATION OF MUCOSA AFTER TREATMENT WITH GLUMA POWERGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319206 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010206

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R