BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT

    MDR report key: 5889781 · Received August 19, 2016

    Report

    Report Number
    1314819-2016-00006
    Event Type
    Injury
    Date Received
    August 19, 2016
    Report Date
    August 16, 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 (B)(4), POLIDENT.

    Description of Event or Problem · 1

    BLISTERS IN HER THROAT [OROPHARYNGEAL BLISTERING]. BLISTERS IN HER MOUTH [BLISTERING OF MOUTH]. SWELLING IN HER MOUTH [SWOLLEN MOUTH]. SWELLING IN HER THROAT [THROAT SWELLING]. BURNS PAINFULLY [BURNING ORAL SENSATION]. BURNS PAINFULLY [ORAL PAIN]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF OROPHARYNGEAL BLISTERING IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT) CREAM (BATCH NUMBER UNKNOWN, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP) UNKNOWN (BATCH NUMBER UNKNOWN, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT AND SUPER POLIGRIP. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT AND SUPER POLIGRIP, THE PATIENT EXPERIENCED OROPHARYNGEAL BLISTERING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BLISTERING OF MOUTH, SWOLLEN MOUTH, THROAT SWELLING, BURNING ORAL SENSATION AND ORAL PAIN. ON AN UNKNOWN DATE, THE OUTCOME OF THE OROPHARYNGEAL BLISTERING, BLISTERING OF MOUTH, SWOLLEN MOUTH, THROAT SWELLING, BURNING ORAL SENSATION AND ORAL PAIN WERE RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE OROPHARYNGEAL BLISTERING, BLISTERING OF MOUTH, SWOLLEN MOUTH AND THROAT SWELLING TO BE RELATED TO POLIDENT AND SUPER POLIGRIP. THE REPORTER CONSIDERED THE BURNING ORAL SENSATION AND ORAL PAIN TO BE RELATED TO POLIDENT AND SUPER POLIGRIP. ADDITIONAL INFORMATION: ADVERSE EVENT (AE) INFORMATION WAS REPORTED BY CONSUMER VIA EMAIL ON 16 AUGUST 2016. CONSUMER REPORTED WHILE WEARING HER DENTURES SHE GOT SWELLING AND BLISTERS IN HER MOUTH AND THROAT, AND IT BURNS PAINFULLY. CONSUMER REPORTED IT WENT AWAY WHEN HER DENTURES WERE OUT, THOUGH SHE DID NOT STATED THAT SHE DISCONTINUED USE OF THE PRODUCTS. CONSUMER REPORTED USING POLIDENT, VARIANT UNSPECIFIED, AND SUPER POLIGRIP, VARIANT UNSPECIFIED. THE ACTION TAKEN WITH POLIDENT AND SUPER POLIGRIP WAS UNKNOWN. FOLLOW UP WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543411 POLIDENT DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other