BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 5656400 · Received May 16, 2016

    Report

    Report Number
    1020379-2016-00008
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    May 11, 2016
    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 OVERNIGHT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    CAN'T SEE AS WELL [LOSS OF VISION]. EYES ARE BOTHERED [EYE DISORDER]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LOSS OF VISION IN A (B)(6) MALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE 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 LOSS OF VISION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), EYE DISORDER AND ACCIDENTAL CONTACT OF PRODUCT WITH EYE. POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE LOSS OF VISION WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE EYE DISORDER AND ACCIDENTAL CONTACT OF PRODUCT WITH EYE WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE LOSS OF VISION AND EYE DISORDER TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS, ADVERSE EVENT REVISION WAS RECEIVED ON 11 MAY 2016. THE CONSUMER REPORTED THAT HE MAY HAD TOUCHED HIS EYES AFTER TOUCHING THE PRODUCT AND NOW HIS EYES WERE BOTHERED AND HE COULD NOT SEE AS WELL. THE CONSUMER WAS ASKED, WHAT SHOULD HE DO IF HE TOUCHED HIS EYES AND SHOULD HE SOUGHT MEDICAL ATTENTION. THE CONSUMER COULD NOT PROVIDE LOT OR EXPIRATION DATE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311441 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other