BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA TABS

    MDR report key: 7637372 · Received June 26, 2018

    Report

    Report Number
    1020379-2018-00028
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    June 18, 2018
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS ASSOCIATED WITH (B)(4), COREGA TABS. COREGA TABS IS MARKETED AS POLIDENT TABLETS IN THE US.

    Description of Event or Problem · 1

    ACCIDENTAL EXPOSURE [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A PATIENT WHO RECEIVED DENTURE CLEANSER (COREGA TABS) TABLET (BATCH NUMBER 091724, EXPIRY DATE JANUARY 2019) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA TABS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA TABS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH COREGA TABS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO COREGA TABS. ADDITIONAL DETAILS: THE CONSUMER INFORMED THAT HE USED THE PRODUCT COREGA TABS AND HE FORGOTTEN TO WASH HIS DENTAL PROSTHESIS BEFORE TO PUT IN HIS MOUTH, AND HE EXPERIENCED A FLAVOR OF SOAP IN HIS MOUTH (ACCIDENTAL EXPOSURE). HOWEVER, IT HAPPENED ONLY ONE TIME ACCORDING TO CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480387 COREGA TABS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. 091724

    Patients

    Seq Age Sex Outcome Treatment
    1 Other