BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 7664911 · Received July 5, 2018

    Report

    Report Number
    1020379-2018-00034
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    June 26, 2018
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 1020379-2018-00034 IS ASSOCIATED WITH ARGUS CASE (B)(4)1, POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    ACCIDENTLY SWALLOWED HALF A TABLET [ACCIDENTAL DEVICE INGESTION]. WAS GOING TO SOAK DENTURE IN HALF A TABLET [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) -YEAR-OLD MALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER MI011713B, EXPIRY DATE 30TH SEPTEMBER 2020) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED DENTURE WEARER. ON (B)(6) 2018, THE PATIENT STARTED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS CONTINUED WITH NO CHANGE. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS, INITIAL AND FOLLOW UP WAS PROCESSED TOGETHER, THE REPORTED HAD STATED THAT HER HUSBAND HAD ACCIDENTLY SWALLOWED HALF A TABLET OF POLIDENT. SHE STATED HE WAS HALF ASLEEP AND MEANT TO PUT IT IN THE CUP TO SOAK HIS DENTURE. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2018, THE REPORTER WANTED TO KNOW IF POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WERE POISONOUS TO SWALLOW AND ACKNOWLEDGED IT WAS THEIR FAULT SINCE THE BOX SAID DO NOT SWALLOW. SHE HAD CALLED POISON CONTROL AND HE WAS OK AT THE MOMENT. SHE DID NOT THINK HE WOULD SEE A DOCTOR. HE WOULD HOWEVER CONTINUE TO USE THE PRODUCT. THE DIRECTIONS FOR USE STATE TO USE 1 TABLET HOWEVER THE CONSUMER HAD INTENDED TO SOAK HIS DENTURE IN HALF A TABLET, THEREFORE AN EVENT WAS ADDED FOR THIS TO BE CONSERVATIVE. INTENTIONALITY FOR THIS EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506978 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. MI011713B

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other