BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 6066709 · Received October 31, 2016

    Report

    Report Number
    1020379-2016-00050
    Event Type
    Injury
    Date Received
    October 31, 2016
    Report Date
    October 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

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    POLIDENT OVERNIGHT WHITENING SOLUTION WAS LEFT IN A GLASS AND WAS INGESTED BY ACCIDENT [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER (B)(4), EXPIRY DATE 23RD MARCH 2016) FOR DENTAL CLEANING. ON (B)(6) 2016, THE PATIENT STARTED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL INGESTION OF DRUG. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND EXPIRED DRUG USED. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, EXPIRED DRUG USED AND ACCIDENTAL INGESTION OF DRUG WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS, THE ADVERSE EVENT INFORMATION WAS RECEIVED ON 19 OCTOBER 2016. THE CONSUMER REPORTED THAT POLIDENT OVERNIGHT WHITENING SOLUTION WAS LEFT IN A GLASS AND WAS INGESTED BY ACCIDENT. UPON GATHERING INFORMATION ABOUT THE PRODUCT THE LOT CODE OF THE PRODUCT SHOWED THE PRODUCT WAS EXPIRED 23 MARCH 2016 AS PER THE SHELF LIFE. THE CONSUMER ASKED WHAT KIND OF ISSUES COULD HAPPEN IF THE SOLUTION WAS INGESTED AND WAS TOLD TO NOT INDUCE VOMITING, RINSE MOUTH OUT, TO DRINK PLENTY OF WATER AND TO SPEAK TO A HEALTH CARE PROFESSIONAL FOR MEDICAL ATTENTION. THE CONSUMER WAS TOLD TO CEASE USING THE EXPIRED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719166 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. MC231613B

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other