BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 6911985 · Received October 3, 2017

    Report

    Report Number
    9610902-2017-00014
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 1, 2017
    Report Date
    September 18, 2017
    Manufacturer
    KULZER, LLC
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION 3E2012008, KULZER, LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF KULZER, LLC (THE MANUFACTURER). INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 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. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR803 AND OUT OF AN ABUNDANCE OF CAUTION. DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED, TO USE THE SMALLEST AMOUNT POSSIBLE, AND NOT TO USE IF PATIENT IS ALLERGIC TO ANY OF THE INGREDIENTS. THE HYGIENIST FAILED TO MAINTAIN ISOLATION OF THE PATIENT'S SOFT TISSUE AND ALSO APPLIED GLUMA DESENSITIZER TOO HEAVILY.

    Description of Event or Problem · 0

    PATIENT REPORTS HYGIENIST USED NO ISOLATION AND TREATED MULTIPLE SITES WITH FIVE COATS OF GLUMA DESENSITIZER. PATIENT REPORTED SHE WENT TO EMERGENCY ROOM FEELING ILL AND WITH BURNS ON HER GUM TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691396 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE KULZER, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other