BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA DENTURE CLEANSING TABLETS

    MDR report key: 10301392 · Received July 21, 2020

    Report

    Report Number
    1020379-2020-00035
    Event Type
    Injury
    Date Received
    July 21, 2020
    Report Date
    June 26, 2020
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    DRANK ALL THE COREGA 3MIN SOLUTION THAT WAS IN HIS GLASS [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A PHARMACIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A ELDERLY MALE PATIENT WHO RECEIVED DENTURE CLEANSER (COREGA DENTURE CLEANSING TABLETS) TABLET (BATCH NUMBER 6F3G, EXPIRY DATE 31ST JANUARY 2022) FOR DRUG USE FOR UNKNOWN INDICATION. ON (B)(6) 2020, THE PATIENT STARTED COREGA DENTURE CLEANSING TABLETS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA DENTURE CLEANSING TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO COREGA DENTURE CLEANSING TABLETS. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE PATIENT DRANK ALL THE COREGA THREE MINUTE SOLUTION THAT WAS IN HIS GLASS. THE PATIENT CALLED THE DOCTOR, WHO TOLD HIM THAT HE SHOULD NOT HAVE DRUNK IT AND DID NOT GIVE HIM ANY OTHER ADVICE. THE PATIENT DRANK A LOT OF WATER AND URINATED THREE TIMES AND HAS NOT FELT ANY DISCOMFORT OR OTHER ADVERSE EVENT AND WENT TO THE PHARMACY ALONE. AS THE CUSTOMER WAS OLD, THE PHARMACIST DID NOT TRY TO EXPLAIN THE PROCESS TO HIM. THE PHARMACIST WOULD ALSO CALL THE POISON CENTER. THE PATIENT DOES NOT EXPERIENCE ANY REACTION. CONSUMER TREATED BY AN HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769836 COREGA DENTURE CLEANSING TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. 6F3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other