BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU GEL

    MDR report key: 6177310 · Received December 15, 2016

    Report

    Report Number
    1314819-2016-00008
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 13, 2016
    Manufacturer
    GLAXOSMITHKLINE LLC
    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 CASE (B)(4), POLIDENT DENTU GEL.

    Description of Event or Problem · 1

    SHE WAS NOW DISABLED. SHE COULD NOT WALK THE HALLS. SHE WAS ON OXYGEN. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DISABILITY IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTU GEL) GEL (BATCH NUMBER (B)(4), EXPIRY DATE UNKNOWN) FOR DENTAL CLEANING. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SMOKER AND EMPHYSEMA. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTU GEL. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTU GEL, THE PATIENT EXPERIENCED DISABILITY (SERIOUS CRITERIA DISABILITY, GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT), UNABLE TO WALK (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT) AND OXYGEN SUPPLEMENTATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE DISABILITY WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE UNABLE TO WALK AND OXYGEN SUPPLEMENTATION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DISABILITY, UNABLE TO WALK AND OXYGEN SUPPLEMENTATION TO BE RELATED TO POLIDENT DENTU GEL. ADDITIONAL DETAILS, THE ADVERSE EVENT INFORMATION WAS REPORTED ON 13 DECEMBER 2016. THE CONSUMER REPORTED USING POLIDENT DENTU GEL TOOTHPASTE FOR YEARS. SHE DID NOT HAVE A CLEAR START DATE. THE CONSUMER LAST USED THE PRODUCT ON (B)(6) 2016. THE CONSUMER WAS (B)(6). SHE STATED SHE WAS NOW DISABLED. SHE STATED THIS PRODUCT HAD NOTHING TO DO WITH HER CONDITION SINCE SHE HAD A HISTORY OF EMPHYSEMA AND HAD BEEN SMOKING FOR 50 YEARS. THE CONSUMER STATED THAT SHE BECAME DISABLED WITHIN THE LAST TEN YEARS. SHE DID NOT GIVE A CLEAR START DATE OF THE DISABILITY. SHE STATED SHE COULD NOT WALK THE HALLS AND THAT SHE WAS ON OXYGEN. THE CONSUMER WOULD NOT SPEAK WITH HER DOCTOR. THE CONSUMER ALSO STATED HER PRODUCT DID NOT HAD A EXPIRY DATE. THE LOT THE CONSUMER PROVIDED WAS 4A12002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825906 POLIDENT DENTU GEL DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC 4A12002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| S