BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA TABS

    MDR report key: 6570479 · Received May 16, 2017

    Report

    Report Number
    1020379-2017-00038
    Event Type
    Injury
    Date Received
    May 16, 2017
    Report Date
    May 3, 2017
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1020379-2017-00038 IS ASSOCIATED WITH ARGUS CASE (B)(4), COREGA TABS. COREGA TABS IS MARKETED IN THE US AS POLIDENT TABLETS.

    Description of Event or Problem · 1

    ACCIDENTAL INGESTA [ACCIDENTAL DEVICE INGESTION]; DROWNING FOR TRYING TO SWALLOW THE TABLET BUT NOTHING HAPPENED [SWALLOWING DIFFICULT]; DISCOMFORT [DISCOMFORT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) MALE PATIENT WHO RECEIVED DENTURE CLEANSER (COREGA TABS) UNKNOWN FOR DENTURE WEARER. CONCURRENT MEDICAL CONDITIONS INCLUDED RENAL IMPAIRMENT (CONTROLLED). 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), SWALLOWING DIFFICULT AND DISCOMFORT. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE SWALLOWING DIFFICULT AND DISCOMFORT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SWALLOWING DIFFICULT AND DISCOMFORT TO BE RELATED TO COREGA TABS. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: INITIAL AND FOLLOW-UP INFORMATION PROCESSED TOGETHER. INITIAL ADVERSE EVENT REPORT FROM DENTIST RECEIVED ON 03-MAY-2017 THROUGH CALL CENTER. THE DENTIST COMMENTED THAT A (B)(6) MALE PATIENT HAD AN ACCIDENTAL INGESTA OF COREGA TABS, HE SAID THAT THIS WAS THE FIRST TIME THE PATIENT WENT WITH HIM. HE SAID THAT THE PATIENT'S WEIGHT IS (B)(6). THE DENTIST COMMENTED THAT HE HAD NOT TALKED WITH THE PATIENT SO, HE COULD NOT GIVE MORE INFORMATION ABOUT THE OUTCOME OF THE EVENT. ON 09-MAY-2017 THE DENTIST COMMENTED THAT THE PATIENT WAS OK, HE HAD ANY DISCOMFORT EXCEPT THAT HE WAS DROWNING FOR TRYING TO SWALLOW THE TABLET BUT NOTHING HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349983 COREGA TABS DENTURE CLEANSER EFT BLOCK DRUG CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other