BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 6767412 · Received August 4, 2017

    Report

    Report Number
    1020379-2017-00061
    Event Type
    Injury
    Date Received
    August 4, 2017
    Report Date
    July 28, 2017
    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

    1020379-2017-00061 IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS.

    Additional Manufacturer Narrative · 1

    REPORT 1020379-2017-00061 IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, 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 ACCIDENTAL INGESTION OF DRUG. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION 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. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER REPORTED THAT, "I WAS SOAKING MY DENTURES OVERNIGHT AND ACCIDENTAL DRUNK SOME OF THE SOLUTION". FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2017. THE CONSUMER STATED, "I DID A DUMB THING. I ACCIDENTALLY PLACED MY POLIDENT SOLUTION NEAR MY WATER GLASS AND I DRANK A BIG GULP OF IT BEFORE I REALIZED. I DRANK A LARGE GLASS OF WATER AFTER DOING SO AS INSTRUCTED. I DID NOT HAVE ANY SIDE EFFECTS." THE CONSUMER DENIED HAVING TO SEE A DOCTOR FOR THIS COMPLAINT AND DENIED CONSENT TO FOLLOW UP WITH HER.

    Description of Event or Problem · 1

    I WAS SOAKING MY DENTURES OVERNIGHT AND ACCIDENTAL DRUNK SOME OF THE SOLUTION [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, 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 ACCIDENTAL INGESTION OF DRUG. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION 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. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER REPORTED THAT, "I WAS SOAKING MY DENTURES OVERNIGHT AND ACCIDENTAL DRUNK SOME OF THE SOLUTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547874 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other