BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 5912453 · Received August 29, 2016

    Report

    Report Number
    1020379-2016-00036
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    August 19, 2016
    Report Date
    August 19, 2016
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT 1020379-2016-00036 IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    GRAND DAUGHTER DRANK A CUP OF OUR PRODUCT'S CLEANING SOLUTION [ACCIDENTAL DEVICE INGESTION BY A CHILD]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION BY A CHILD IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER MC034613B, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. ON (B)(6) 2016, THE PATIENT STARTED POLIDENT DENTURE CLEANSER TABLETS. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER TABLETS, 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 UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION BY A CHILD TO BE RELATED TO POLIDENT DENTURE CLEANSER 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 CONSUMER REPORTED THAT SHE BELIEVED HER GRAND DAUGHTER DRANK A CUP OF THEIR PRODUCT'S CLEANING SOLUTION A FEW MINUTES AGO ON (B)(6) 2016. THE CONSUMER STATED SHE SAW THE CHILD NEXT TO AN EMPTY CUP THAT WAS ONCE FILLED WITH AN UNSPECIFIED AMOUNT OF PRODUCT, WIPING HER MOUTH. THE CONSUMER STATED WHEN SHE ASKED THE CHILD IF SHE DRANK WHAT WAS IN THE CUP, THE CHILD SAID YES. NO OTHER ADVERSE EVENTS WERE REPORTED. THE CONSUMER PLANNED TO CONTACT THEIR HEALTH CARE PROFESSIONAL ON THE MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561623 POLIDENT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. MC034613B

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other