BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)

    MDR report key: 9877965 · Received March 25, 2020

    Report

    Report Number
    3003721894-2020-00067
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 15, 2020
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    OTHER DAY I WAS COUGHING AND SQUEEZING AND MY DENTURES ALMOST WENT DOWN MY THROAT AND I CHOKED [CHOKING]. THE OTHER DAY I PUT IN HOPING TO FINISH LUNCH I STARTED COUGHING [COUGH]. BUT THIS IS THE FIRST ONE I HAD SOMETHING WHERE I DONT KNOW HOW BAD I HURT MYSELF [PAIN]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)) CREAM (BATCH NUMBER P597, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2019, THE PATIENT STARTED SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA). ON (B)(6) 2020, 147 DAYS AFTER STARTING SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, PAIN AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, COUGH AND PAIN WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA). THE REPORTER CONSIDERED THE COUGH AND PAIN TO BE RELATED TO SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON 15 JANUARY 2020. THE CONSUMER REPORTED THAT "I AM CALLING IN ABOUT POLIGRIP EXTRA CARE, NOT SURE IF IT IS THE DENTIST OR THIS STUFF NOT WORKING. I HAD A HARD TIME KEEPING THEM IN. I DRINK HOT COFFEE THEY FALL OUT NOT EVEN STAY IN FOR 15 MINUTES. THE OTHER DAY I PUT IN HOPING TO FINISH LUNCH I STARTED COUGHING. I COUGH A LOT WITH MY DENTURES IN. OTHER DAY I WAS COUGHING AND SQUEEZING AND MY DENTURES ALMOST WENT DOWN MY THROAT AND I CHOKED WE GOT THEM OUT BUT IT FOR ABOUT THREE OR FOUR DAYS. WHY IS THIS HAPPENING? I ONLY HAD THREE BAD ONES THEY TALKED ME INTO GETTING THEM. I ALMOST SENT OUT AN EMAIL ABOUT IT. SEEMS LIKE I DO NEED THEM. HOW DO I KEEP THESE IN MY MOUTH? IT HOLDS UNTIL I EAT. STAYS IN WHEN I EAT COLD STUFF, I CAN'T DRINK HOT COFFEE ANYMORE. THIS IS THE FOURTH TUBE. THAT DID NOT HOLD. BUT THIS IS THE FIRST ONE I HAD SOMETHING WHERE I DON'T KNOW HOW BAD I HURT MYSELF. I COULD NOT EAT FOR A COUPLE DAYS. THE FACT WHEN IT DID THAT IT GOT ME WENT HALF WAY DOWN MY THROAT. I THREW ALL THE OTHER TUBES AWAY.". FOLLOW UP INFORMATION WAS RECEIVED ON 31 JANUARY 2020 VIA RETURNED CONSUMER AUTHORIZATION FORM. CONSUMER HAS PROVIDED PHYSICIAN ADDRESS DETAILS AND LOT NUMBER P59Y. SUSPECT SUPER POLIGRIP EXTRA CARE WITH LOT NUMBER P59Y WAS UPDATED IN THE CASE. FOLLOW UP INFORMATION WAS RECEIVED ON 25 FEBRUARY 2020 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT NUMBER (B)(4) (ISSUE NUMBER) FOR LOT NUMBER FS9Y. THE INVESTIGATION REPORT INCLUDED THAT, THE PRODUCT SAMPLE WAS RECEIVED. TESTING WAS CARRIED OUT ON THE COMPLAINT SAMPLE AND RESULTS MET SPECIFICATION REQUIREMENTS INDICATING THAT THE PRODUCT WAS MANUFACTURED APPROPRIATELY AND COMPLIED WITH THE REQUIRED QUALITY STANDARDS. QA ANALYSIS REVEALED THE COMPLAINT TO BE UNSUBSTANTIATED. SUSPECT SUPER POLIGRIP EXTRA CARE WITH LOT NUMBER FS9Y WAS UPDATED IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340135 SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA) DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD FS9Y

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other