BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM

    MDR report key: 11207025 · Received January 21, 2021

    Report

    Report Number
    3003721894-2021-00027
    Event Type
    Injury
    Date Received
    January 21, 2021
    Report Date
    January 12, 2021
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    ABOUT A YEAR AND A HALF AGO I CAME DOWN WITH DYSTONIA [DYSTONIA]. I FOUND OUT THAT I WAS BREAKING OUT IN HIVES WHEN I USED THE REGULAR PRODUCT WITH ZINC IN IT. [HIVES]. MY ABILITY TO TALK IS VERY LIMITED NOW AS I NO LONGER HAVE ANY CONTROL OVER MY JAW. IT OPENS AND CLOSES ALL DAY LONG WHEN IT WANTS TO. [JAW MOVEMENTS DISTURBANCE]. MY ABILITY TO TALK IS VERY LIMITED NOW [SPEECH DISORDER]. EVERY COUPLE HOURS I HAVE TO GO AND CLEAN THEM AND RE GLUE THEM BACK IN. [DEVICE USE ISSUE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DYSTONIA IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)) CREAM (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM) CREAM (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. CONCURRENT MEDICAL CONDITIONS INCLUDED DISABILITY, NEOPLASM AND TOOTH EXTRACTION. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT) AND SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT) AND SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM, THE PATIENT EXPERIENCED DYSTONIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), HIVES, JAW MOVEMENTS DISTURBANCE, SPEECH DISORDER, DEVICE USE ISSUE AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DYSTONIA, HIVES, JAW MOVEMENTS DISTURBANCE, SPEECH DISORDER, DEVICE USE ISSUE AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DYSTONIA, HIVES, JAW MOVEMENTS DISTURBANCE, SPEECH DISORDER AND DEVICE USE ISSUE TO BE RELATED TO SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT) AND SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM. 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 VIA CALL CENTER REPRESENTATIVE (EMAIL) ON (B)(6) 2021. CONSUMER REPORTED THAT, "I AM WRITING THIS IN HOPES THAT YOU MIGHT BE ABLE TO HELP ME IN SOME WAY. I AM A (B)(6) YEAR OLD DISABLED VETERAN. A FEW YEARS AGO, I HAD A LARGE TUMOR IN MY SINUSES THAT RESULTED IN THE REMOVAL OF MY TOP ROW OF TEETH, THE ROOF OF MY MOUTH AS WELL AS A LOT OF THE BONE THAT'S THERE TO HOLD THE TEETH IN. SEEING AS HOW MY LOWERS WEREN'T SO GREAT I HAD THOSE TAKEN OUT AT THE SAME TIME. I WAS FINALLY FITTED FOR DENTURES AND FOR ABOUT 2 YEARS EVERYTHING WAS FINE. I'VE BEEN USING THE POLIGRIP ZINC FREE SINCE DAY ONE. I FOUND OUT THAT I WAS BREAKING OUT IN HIVES WHEN I USED THE REGULAR PRODUCT WITH ZINC IN IT. ABOUT A YEAR AND A HALF AGO I CAME DOWN WITH DYSTONIA. A WEIRD MUSCLE CONDITION THAT HAS AFFECTED THE MUSCLES IN MY UPPER BODY MAINLY IN MY JAW AND NECK MUSCLES. MY ABILITY TO TALK IS VERY LIMITED NOW AS I NO LONGER HAVE ANY CONTROL OVER MY JAW. IT OPENS AND CLOSES ALL DAY LONG WHEN IT WANTS TO. THE PROBLEM I'M HAVING DUE TO THIS CONDITION IS THAT MY LOWER DENTURES ONLY STAY PUT FOR MAYBE 2 HOURS TOPS. I LITERALLY GO THRU A TUBE OF THE POLIGRIP IN ABOUT 2 DAYS. EVERY COUPLE HOURS I HAVE TO GO AND CLEAN THEM AND RE GLUE THEM BACK IN. IT'S EXTREMELY FRUSTRATING AND ITS GETTING EXPENSIVE. MY WIFE BUYS THE DOUBLE PACKS. WE WAIT WEEKLY FOR COUPONS TO COME OUT BUT THEY AREN'T ENOUGH. WE WERE WONDERING IF YOU HAD ANY OTHER OPTIONS WE COULD LOOK INTO? ANY PLACES TO GET MORE COUPONS? ANY PRODUCTS YOU ARE WORKING ON THAT I COULD TEST OUT? DUE TO MY SURGERIES DENTAL IMPLANTS AREN'T AN OPTION FOR ME UNFORTUNATELY. ANY HELP IN ANY DIRECTION WOULD BE GREATLY APPRECIATED. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107210 SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other