BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 355170 · Received October 8, 2001

    Report

    Report Number
    2650037-2001-00001
    Event Type
    Other
    Date Received
    October 8, 2001
    Date of Event
    June 21, 2001
    Report Date
    October 5, 2001
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    KOT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CONSUMER WITH A HISTORY OF BENIGN PROSTATIC HYPERPLASIA AND URINARY FREQUENCY REPORTED THAT THE CONSUMER USED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE WHICH APPEARED "LUMPY" AND WAS A "DIRTY BROWN COLOR" FROM A NEWLY OPENED TUBE AND EXPERIENCED NAUSEA, STOMACH PAIN, AN INCREASE IN URINARY FREQUENCY, PAINFUL URINATION AND A BLADDER INFECTION WITHIN SEVERAL DAYS OF PRODUCT USE. THE CONSUMER DENIED A HISTORY OF BLADDER OR URINARY TRACT INFECTIONS. THE CONSUMER REPORTED THAT THE CONSUMER CONTINUED USING THE PRODUCT FOR ONE WEEK DESPITE ONGOING SYMPTOMS THAT LASTED THE ENTIRE DAY AND GRADUALLY WORSENED DURING THE PERIOD OF PRODUCT USE. WITH ALL OF THE CONSUMER'S SYMPTOMS ONGOING, THE CONSUMER REPORTED THAT THE CONSUMER CALLED AN AMBULANCE AND WAS ADMITTED TO THE EMERGENCY ROOM. THE CONSUMER REPORTED THAT THE CONSUMER WAS HOSPITALIZED FOR A TOTAL OF 2 WEEKS AT 2 DIFFERENT HOSPITALS. THE CONSUMER REPORTED THAT THE FIRST HOSPITAL WAS UNABLE TO DETERMINE THE CAUSE OF THE CONSUMER'S BLADDER INFECTION AND TRANSFERRED THE CONSUMER TO A SECOND HOSPITAL. THE CONSUMER REPORTED THAT THE CONSUMER WAS GIVEN INTRAVENOUS ANTIBIOTICS WHILE IN THE HOSPITAL. IT IS UNKNOWN WHAT TEST(S) WERE PERFORMED WHILE THE CONSUMER WAS HOSPITALIZED. THE CONSUMER REPORTED THAT ALL OF THE CONSUMER'S SYMPTOMS RESOLVED WHILE HOSPITALIZED AND THE CONSUMER WAS DISCHARGED WITH A PRESCRIPTION FOR NITROMACRO 50 MG CAPSULE TO BE TAKEN ONE AT BEDTIME TO PREVENT ANOTHER BLADDER INFECTION. THE CONSUMER REPORTED THAT THE CONSUMER HAS BEEN TAKING NITROMACRO 50 MG SINCE THE CONSUMER WAS DISCHARGED FROM THE HOSPITAL, APPROXIMATELY 3 AND 1/2 MONTHS, AND HAS NOT HAD A RECCURRENCE OF URINARY SYMPTOMATOLOGY. THE CONSUMER REPORTED THAT THE CONSUMER HAS BEEN USING SUPER POLIGRIP ORIGINAL FOR OVER 15 YEARS WITHOUT INCIDENT AND HAS RESUMED USE WITHOUT INCIDENT. THE CONSUMER GRANTED THE MANUFACTURER PERMISSION TO CONTACT THE CONSUMER'S PRIMARY CARE PHYSICIAN BECAUSE THE PRIMARY CARE PHYSICIAN HAD VISITED WHILE THE CONSUMER WAS HOSPITALIZED AND WAS AWARE OF THE SYMPTOMS THE CONSUMER EXPERIENCED WITH PRODUCT USE. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45328 SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOT BLOCK DRUG COMPANY, INC. * HC06LV

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization CARDURA (DOXAZOSIN MESILATE), ROUTE: PO, UNK/UNK.