BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 8174683 · Received December 18, 2018

    Report

    Report Number
    9610902-2018-00006
    Event Type
    Injury
    Date Received
    December 18, 2018
    Report Date
    December 18, 2018
    Manufacturer
    KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIRECTIONS FOR USE STATE, "PROTECT MUCOUS MEMBRANES BY USING A RUBBER DAM". EVEN THOUGH THIS IS CLEARLY THE RESULT OF USER ERROR, THE TREATING DDS HAD THE PATIENT STOP HIS MEDICATION AFTER CONSULTING WITH THE PATIENT'S PHYSICIAN FOR A WEEK AND HAD HIM UNDER OBSERVATION FOLLOWING ANTIBIOTICS TO PREVENT SUPER INFECTION. 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

    DENTIST HAD A CASE OF PATIENT PRESENTING WITH DENTINE SENSITIVITY AND "RECOMMEND" THE USE OF GLUMA DESENSITIZER. BUT WHILE HANDLING THE GLUMA IN THE ORAL CAVITY THE PATIENT SPREAD THE GLUMA PLACED "THROUGH" HIS TONGUE ALL OVER HIS CHEEK AND PALATE. HE WAS DRINKING LUKEWARM WATER FOR THE PAST DAY AND HAD SLIGHT DISCOMFORT EARLIER. HE REPORTED AFTER 24 HOURS WITH WIDESPREAD FIRM SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014964 GLUMA DESENSITIZER DESENSITIZER KLE KULZER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention