BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXADENT COMPLETE

    MDR report key: 445918 · Received December 17, 2002

    Report

    Report Number
    MW4003451
    Event Type
    Injury
    Date Received
    December 17, 2002
    Date of Event
    November 19, 2002
    Report Date
    December 17, 2002
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO
    Product Code
    KOQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STATED THAT THEY HAVE BEEN A DIABETIC FOR SEVERAL YEARS. CURRENTLY THEY ARE TAKING LANTUS AND HUMALOG INSULIN. PT TAKES EIGHT UNITS OF HUMOLOG IN THE MORNING AND AT SUPPER. PRIOR TO BEDTIME, PT TAKES THIRTY UNITS OF LANTUS. PT STATED THAT THEY BEGAN USING FIXADENT COMPLETE FOR THE ADHESION OF THEIR DENTURES IN NOVEMBER 2002. PT IMMEDIATELY NOTICED THAT THEIR BLOOD SUGAR READINGS WERE ERRATIC. PT MONITORS THEIR BLOOD GLUCOSE LEVELS 4-6 TIMES A DAY. PT AVERAGES @ 100. PT STATED THAT THEY USED THE FIXADENT FOR APPROX TWO WEEKS AND BLOOD SUGARS AVERAGED @ 120. PT STATED THAT THEY HAD TO SUPPLEMENT WITH THE HUMALOG. DURING THIS TIME, BLOOD SUGAR READINGS WERE AS HIGH AS 240. IN DECEMBER 2002, PT DISCONTINUED THE USE OF FIXADENT AND WITHIN ONE DAY THEY OBSERVED THAT BLOOD SUGAR LEVELS RETURNED TO THE NORM. PT STATED THAT THEY CONTACTED THE MFR AND THEY STATED THAT NO SUGAR WAS IN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXADENT COMPLETE DENTURE ADHESIVE KOQ PROCTER & GAMBLE MANUFACTURING CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *