BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G.U.M SECURE

    MDR report key: 16103953 · Received January 4, 2023

    Report

    Report Number
    MW5114183
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 12, 2022
    Report Date
    December 30, 2022
    Manufacturer
    UNKNOWN
    Product Code
    KOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    STARTED TO USE THE GUM SECURE AND IT BURNT MY GUM ON MY LOWER DENTURE AND IT MADE MY DENTURE SOFT IN PLACES. LOT NUMTU0140CA0215, (B)(4), ON (B)(6) 2026. VERY DISAPPOINTED DID NOT DO WHAT IT CLAIMS I STOPPED AFTER TWO HOURS AND CLEANED MY DENTURE AND FOUND IT SOFT IN PLACES. THIS WAS NOT A TEST BOUGHT IT IN GOOD FAITH FROM THE PHARMACY. MADE IN AUSTRIA FOR SUNSTAR GUM SE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132001 G.U.M SECURE ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (40-100&) KOQ UNKNOWN TU10140CA0215

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other TYLENOL THREE.| VITAMIN A, VITAMIN B AND VITAMIN C.