BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 6572852 · Received May 17, 2017

    Report

    Report Number
    1020379-2017-00039
    Event Type
    Death
    Date Received
    May 17, 2017
    Report Date
    May 11, 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 ARGUS (B)(4), POLIDENT DENTURE CLEANSER TABLETS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HE PASSED AWAY [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A MALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE 2014) FOR PRODUCT USED FOR UNKNOWN INDICATION. 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 UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE RELATED TO POLIDENT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 11 MAY 2017. CONSUMER'S WIFE REPORTED SHE HAD A BOX THAT EXPIRED IN 2014, HER HUSBAND USED IT BEFORE EXPIRATION BUT HE PASSED AWAY ON UNKNOWN DATE.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A MALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE 2014) FOR PRODUCT USED FOR UNKNOWN INDICATION. 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 UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE RELATED TO POLIDENT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 11 MAY 2017. CONSUMER'S WIFE REPORTED SHE HAD A BOX THAT EXPIRED IN 2014, HER HUSBAND USED IT BEFORE EXPIRATION BUT HE PASSED AWAY ON UNKNOWN DATE. FOLLOW UP INFORMATION WAS RECEIVED ON 10 JUNE 2017. THE CONSUMER REPORTED THAT THEY DISPOSED THE PRODUCT ON UNSPECIFIED DATE. HER HUSBAND DIED APPROXIMATELY 4 YEARS AGO. PATIENT DIED BECAUSE OF NATURAL CAUSES. THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE UNRELATED TO POLIDENT DENTURE CLEANSER TABLETS. THIS CASE WILL BE DELETED FROM THE DATABASE AS THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE CASE. COMMENT: *DOWNGRADE REPORT*

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353399 POLIDENT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O