BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 378624 · Received February 22, 2002

    Report

    Report Number
    2650037-2002-00001
    Event Type
    Other
    Date Received
    February 22, 2002
    Date of Event
    June 1, 1994
    Report Date
    February 18, 2002
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THEY BEGAN USING SUPER POLIGRIP DENTURE ADHESIVE CREAM 5 TIMES PER DAY AND WITHIN ONE YEAR OF BEGINNING PRODUCT USE THEY EXPERIENCED A HEART ATTACK. THE CONSUMER REPORTED THAT THIS EVENT HAPPENED APPROXIMATELY 8 YEARS AGO. THE CONSUMER REPORTED THAT THEY WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL. THE CONSUMER REPORTED THAT THEY UNDERWENT A BALLOON ANGIOPLASTY AND REMAINED IN THE HOSPITAL FOR APPROXIMATELY ONE WEEK. THE CONSUMER REPORTED THAT THEY WERE DIAGNOSED WITH HIGH BLOOD PRESSURE, DIABETS, AND ANGINA AND DENIED USING ANY OTC OR PRESCRIPTION DRUGS PRIOR TO THEIR HEART ATTACK. THE CONSUMER REPORTED THAT THEY DRINK 1 CUP OF DECAFFICINATED COFFEE A DAY AND HAS AN OCCASIONAL BEER. THE CONSUMER REPORTED THAT IN THE PAST THEY SMOKED 3 PACKS OF CIGARETTES A DAY FOR 35 YEARS BUT STOPPED SMOKING APPROXIMATELY TWO YEARS PRIOR TO THEIR HEART ATTACK. THE CONSUMER REPORTED THAT THEY CONTINUED TO USE THE PRODUCT AND ONE-YEAR AFTER THEIR HEART ATTACK THEY BECAME "CLOGGED UP" AGAIN AND WENT TO THE EMERGENCY ROOM BECAUSE THEY THOUGHT THEY WERE HAVING ANOTHER HEART ATTACK. THE CONSUMER REPORTED THAT PT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT HEART VALVE REPLACEMENT AND DOUBLE BY-PASS SURGERY. THE CONSUMER REPORTED THAT THEY WERE DISCHARGED FROM THE HOSPITAL APPROXIMATELY 3 WEEKS LATER. THE CONSUMER REPORTED THAT THEIR PHYSICIAN INFORMED THAM THAT THEY HAD PLAQUE IN THEIR ARTERIES AND PLACED THE CONSUMER ON A LOW CHOLESTEROL DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOO BLOCK DRUG COMPANY, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O 4. GLUCOTROL (GLIPIZIDE), ROUTE: PO,01/01/1994/UNK| 2. ATENOLOL (ATENOLOL), ROUTE: PO, 01/01/1994/UNK| 3. WARFARIN (WARFARIN), ROUTE: PO, 01/01/1994/UNK.| 1. CAPTOPRIL (CAPTOPRIL), ROUTE: PO,01/01/1994/UNK