BEUDAMED
    FDA Adverse Event Summary report: N

    FIXODENT CONTROL

    MDR report key: 570519 · Received February 2, 2005

    Report

    Report Number
    MW4003864
    Date Received
    February 2, 2005
    Date of Event
    October 18, 2004
    Report Date
    October 22, 2004
    Manufacturer
    *
    Product Code
    KOQ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT NEVER USED ANY PRODUCT BEFORE ON THEIR DENTURES. UPON VISITING DENTIST FOR A ROUTINE CHECKUP DENTIST PROVIDED THEM WITH A TUBE (NO CHARGE) OF FIXODENT CONTROL DENTURE ADHESIVE CREAM. PT DID NOT USE THIS PRODUCT UNTIL 4 DAYS LATER AT ABOUT 12 NOON. PT AWOKE AT ABOUT 4 AM THE NEXT DAY, WITH A FEELING THAT THEIR HEART "WAS RACING" AND HAD HIVES ON ARMS. THEY CALLED 911, AND WERE TAKEN TO HOSPITAL, WHERE THEY WERE RELEASED 4 OR 5 HOURS LATER. PT HAS NOT RETURNED TO USING THIS PRODUCT; AND HAS NO NEW ADVERSE EVENTS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT CONTROL DENTURE ADHESIVE CREAM KOQ * * T3368/95216424

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR