BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 6682586 · Received June 30, 2017

    Report

    Report Number
    1020379-2017-00051
    Event Type
    Death
    Date Received
    June 30, 2017
    Report Date
    June 27, 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

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

    Description of Event or Problem · 1

    DEATH NOS [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DEATH NOS IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER K161413A, EXPIRY DATE UNKNOWN) FOR DENTAL CLEANING. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CANCER. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTURE CLEANSER TABLETS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED DEATH NOS (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE OUTCOME OF THE DEATH NOS WAS FATAL. THE PATIENT DIED ON (B)(6) 2017. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH NOS TO BE RELATED TO POLIDENT 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 DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 27 JUNE 2017. THE CONSUMER STATED HIS WIFE PASSED AWAY AFTER USING THE POLIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461788 POLIDENT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. K161413A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O