BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREGA PERFORMANCE MAXIMUM/FRANCE

    MDR report key: 356251 · Received October 14, 2001

    Report

    Report Number
    9681138-2001-00001
    Event Type
    Death
    Date Received
    October 14, 2001
    Date of Event
    September 1, 2001
    Report Date
    October 9, 2001
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SPOUSE USED COREGA PERFORMANCE MAXIMUM, WHICH IS SIMILAR TO SUPER POLIGRIP ORIGINAL MARKETED IN THE U.S, FOR 2 DAYS AND EXPERIENCED ORAL IRRITATION. THE CONSUMER REPORTED THAT SPOUSE CONTINUED TO USE THE PRODUCT FOR 10 DAYS AND EXPERIENCED "GASTRIC TROUBLE" AND WAS ADMITTED TO THE HOSPITAL FOR HEPATITIS B. IT IS UNKNOWN IF THE CONSUMER'S SPOUSE HAD ANY TEST(S) PERFORMED OR IF SPOUSE HAD RECEIVED ANY MEDICAL TREATMENT WHILE IN THE HOSPITAL. ON FOLLOW-UP, THE CONSUMER REPORTED THAT SPOUSE DIED FROM HEPATITIS B. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46177 COREGA PERFORMANCE MAXIMUM/FRANCE DENTURE ADHESIVE KOO BLOCK DRUG COMPANY, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H