BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 12712066 · Received October 28, 2021

    Report

    Report Number
    1020379-2021-00057
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    INADVERTENTLY DRANK [THE WATER] THAT CONTAINED POLIDENT EFFERVESCENT TABLET [ACCIDENTAL DEVICE INGESTION] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2021, THE PATIENT STARTED POLIDENT DENTURE CLEANSER TABLETS. ON (B)(6) 2021, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH POLIDENT DENTURE CLEANSER TABLETS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION RECEIVED FROM CONSUMER VIA CALL CENTER REPRESENTATIVE (EMAIL) ON 19OCT2021. THE REPORTER STATED THAT, "MY FATHER INADVERTENTLY DRANK [THE WATER] ABOUT HALF AN HOUR AGO BUT IS CURRENTLY NOT EXHIBITING ANY SYMPTOMS. IT IS NOT CONVENIENT TO HAVE SAFETY STAFF CONTACT ME BACK. I WOULD LIKE TO TRY TO TAKE CARE OF IT MYSELF FIRST. IT WAS THE REGULAR FORMULA IN A GREEN BOX. UPDATE INFORMATION AFTER CALL BACK: MY FATHER INADVERTENTLY DRANK [THE WATER] ABOUT HALF AN HOUR AGO BUT IS CURRENTLY NOT EXHIBITING ANY SYMPTOMS. FOR NOW, I WOULD LIKE TO KNOW THE INGREDIENTS OF THE POLIDENT EFFERVESCENT TABLETS SO I CAN ASSESS THE SITUATION MYSELF FIRST AND DETERMINE WHAT TO DO. ARE THERE ANY INGREDIENTS THAT ARE VERY HARMFUL? FOR INSTANCE, ARE THERE ANY SYMPTOMS THAT I SHOULD OBSERVE? SHOULD I JUST WAIT BEFORE GOING TO SEE A DOCTOR BECAUSE HE IS NOT EXHIBITING ANY SYMPTOMS? I DO NOT HAVE THE BOX WITH ME, SO I'D LIKE TO KNOW THE INGREDIENTS OF THE EFFERVESCENT TABLETS. IT IS NOT CONVENIENT TO HAVE SAFETY STAFF CONTACT ME BACK. I WOULD LIKE TO TRY TO TAKE CARE OF IT MYSELF FOR NOW. IT WAS THE REGULAR FORMULA IN A GREEN BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608860 POLIDENT DENTURE CLEANSER TABLETS POLIDENT DENTURE CLEANSER TABLETS EFT BLOCK DRUG CO., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other