BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITZING POWERGEL

    MDR report key: 8339832 · Received February 14, 2019

    Report

    Report Number
    9610902-2019-00001
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    October 16, 2018
    Report Date
    February 6, 2019
    Manufacturer
    KULZER, GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KULZER HAS NOTIFIED THE TREATING DDS AND EDUCATED THEM ON THE PROPER ISOLATION TECHNIQUES THAT ARE RECOMMENDED AND STATED WITHIN THE DFU. WE WILL CONTINUE TO KEEP IN TOUCH WITH THE PATIENT FOR ANY UPDATES REGARDING EXTENDED SYMPTOMS AS SHE CONTINUES TO EXPERIENCE AN ALTERED STATE OF TASTES, AFTER CONTACTING ALL PARTIES INVOLVED, IT IS APPARENT THAT THIS IS DUE TO USER ERROR AS THERE WAS NOT ISOLATION USED AND THE DFU WAS NOT FOLLOWED. THIS 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 STILL EXPERIENCING AN ALTERED STATE OF TASTE AND HAS SOUGHT TREATMENT WITH A SECONDARY PROVIDER. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. KULZER LLC IS REPORTING THIS INCIDENT ON BEHALF OF KULZER, GMBH STATED BY EXEMPTION E2012008: GRANTING PERMISSION FOR THE IMPORTER (KULZER, LLC), TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY KULZER GMBH AND IMPORTED INTO THE UNITED STATES OF AMERICA BY KULZER, LLC. THIS SINGLE MDR WILL SATISFY THE REPORTING OBLIGATION FOR BOTH FIRMS UNDER 21 CFR PARTS 803.40, 803.42, 803.50(A)(1), 803.50(A)(2) AND 803.52.

    Description of Event or Problem · 0

    PATIENT WENT TO TREATING DDS AND HAD GLUMA APPLIED TO THEIR ENTIRE DENTITION. MATERIAL WAS APPLIED BY THE HYGIENIST. NO ISOLATION WAS USED, MATERIAL WAS NOT RINSED AND THE PATIENT WAS SENT HOME AND INSTRUCTED TO NOT EAT OR DRINK ANYTHING FOR 30 MINUTES. PATIENT EXPERIENCED BURNING AND ALTERED TASTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135077 GLUMA DESENSITZING POWERGEL DESENSITIZER LBH KULZER, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other