BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA TABS BIO FORMULA

    MDR report key: 6689085 · Received July 6, 2017

    Report

    Report Number
    1020379-2017-00050
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 15, 2017
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), COREGA TABS BIO FORMULA. COREGA TABS BIO FORMULA IS MARKETED AS POLIDENT IN THE US.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), COREGA TABS BIO FORMULA. COREGA TABS BIO FORMULA IS MARKETED AS POLIDENT IN THE US.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION BY A CHILD IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER 10791-02-001 (COREGA TABS BIO FORMULA) TABLET FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA TABS BIO FORMULA. ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING COREGA TABS BIO FORMULA, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION BY A CHILD (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION BY A CHILD WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION BY A CHILD TO BE RELATED TO COREGA TABS BIO FORMULA. ADDITIONAL INFORMATION CASE REPORTED TO PV THROUGH CALL CENTRE REPRESENTATIVE. (B)(6) FEMALE DRANK SOME LIQUID WITH COREGA OXIGENO BIOACTIVO (ACCIDENTAL EXPOSURE) ON (B)(6) 2017. SHE WAS ADVISED TO GO TO HOSPITAL EMERGENCY ROOM FOR EXAMINATION. ON 19/06/2017 PV CONTACTED FOR FU INFORMATION. THE PATIENT DID NOT PRESENT ANY ADVERSE EVENT BUT AS PRECAUTION, THEY WENT TO HOSPITAL EMERGENCY ROOM FOR EXAMINATION. AT MEDICAL EXAMINATION, THE PATIENT DID NOT PRESENT ANY EVENT SO NO TREATMENT WAS PRESCRIBED. AT REPORTING DATE NO EVENTS HAD APPEARED. THE CASE IS CLOSED. FOLLOW UP INFORMATION RECEIVED 06 JULY 2017 THE EVENT OCCURRED ON (B)(6) 2017 AND SHE WENT TO EMERGENCY ROOM FOR EXAMINATION ON (B)(6) 2017.

    Description of Event or Problem · 1

    ACCIDENTAL EXPOSURE [ACCIDENTAL DEVICE INGESTION BY A CHILD]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION BY A CHILD IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER 10791-02-001 (COREGA TABS BIO FORMULA) TABLET FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA TABS BIO FORMULA. ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING COREGA TABS BIO FORMULA, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION BY A CHILD (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION BY A CHILD WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION BY A CHILD TO BE RELATED TO COREGA TABS BIO FORMULA. ADDITIONAL INFORMATION: CASE REPORTED TO PV THROUGH CALL CENTRE REPRESENTATIVE. (B)(6) FEMALE DRANK SOME LIQUID WITH COREGA OXIGENO BIOACTIVO (ACCIDENTAL EXPOSURE) ON (B)(6) 2017. SHE WAS ADVISED TO GO TO HOSPITAL EMERGENCY ROOM FOR EXAMINATION. ON 19/06/2017 PV CONTACTED FOR FU INFORMATION. THE PATIENT DID NOT PRESENT ANY ADVERSE EVENT BUT AS PRECAUTION, THEY WENT TO HOSPITAL EMERGENCY ROOM FOR EXAMINATION. AT MEDICAL EXAMINATION, THE PATIENT DID NOT PRESENT ANY EVENT SO NO TREATMENT WAS PRESCRIBED. AT REPORTING DATE NO EVENTS HAD APPEARED. THE CASE IS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470441 COREGA TABS BIO FORMULA DENTURE CLEANSER EFT BLOCK DRUG CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Other