BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 8023065 · Received October 31, 2018

    Report

    Report Number
    1020379-2018-00065
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    I TOOK A DRINK TO SWALLOW THE PILL AND I DRANK THE POLIDENT [ACCIDENTAL DEVICE INGESTION] I JUST HAVE ITCHING BUT I ALWAYS GET ITCHY [PRURITUS].. 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 DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNKNOWN, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRURITUS. THE ACTION TAKEN WITH POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND PRURITUS WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND PRURITUS TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON 25 OCTOBER 2018. CONSUMER REPORTED THAT, "I DID SOMETHING REALLY STUPID. I UH, IT WAS DARK AND I TOOK A PILL AND I HAD MY DENTURES IN WITH THE POLIDENT. I TOOK A DRINK TO SWALLOW THE PILL AND I DRANK THE POLIDENT. I JUST HAVE ITCHING BUT I ALWAYS GET ITCHY. I DO NOT HAVE THE BOX I THINK IT IS THE 40 CT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866213 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other