BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP CUSHION COMFORT

    MDR report key: 12245267 · Received July 29, 2021

    Report

    Report Number
    3003341442-2021-00014
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 12, 2021
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT BREAKS MY TONGUE OUT / MY TONGUE WAS BLISTERED UP [TONGUE ERUPTION] MY TONGUE GO SWELLING / MY TONGUE HAD SWELLED UP SO BIG [SWOLLEN TONGUE] IT PUT BLISTERS IN MY MOUTH / THE INSIDE OF MY MOUTH WAS BLISTERED UP [BLISTERING OF MOUTH] I HAD NO FEELING IN IT [TONGUE SENSATION LOSS OF] I COULDN'T BREATHE / I FIND MYSELF CHOKING BECAUSE I CANT BREATHE GOOD [DIFFICULTY BREATHING] I COULDN'T AND TALK [SPEECH DISORDER] MY TONGUE WAS AND SORE [SORE TONGUE] MY THROAT IT BOTHERS ME WHEN I SWALLOW [THROAT DISCOMFORT] AT TIMES I FIND MYSELF CHOKING [CHOKING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) AND DESCRIBED THE OCCURRENCE OF TONGUE ERUPTION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP CUSHION COMFORT) CREAM (BATCH NUMBER 184380, EXPIRY DATE 6TH AUGUST 2023) FOR DENTURE WEARER. ON (B)(6) 2021, THE PATIENT STARTED POLIGRIP CUSHION COMFORT. ON (B)(6) 2021, AN UNKNOWN TIME AFTER STARTING POLIGRIP CUSHION COMFORT, THE PATIENT EXPERIENCED TONGUE ERUPTION, SWOLLEN TONGUE, BLISTERING OF MOUTH, TONGUE SENSATION LOSS OF, DIFFICULTY BREATHING, SPEECH DISORDER, SORE TONGUE, THROAT DISCOMFORT AND CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH POLIGRIP CUSHION COMFORT WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE TONGUE ERUPTION, SWOLLEN TONGUE, BLISTERING OF MOUTH, TONGUE SENSATION LOSS OF, DIFFICULTY BREATHING, SPEECH DISORDER, SORE TONGUE, THROAT DISCOMFORT AND CHOKING WERE UNKNOWN. THE REPORTER CONSIDERED THE TONGUE ERUPTION, SWOLLEN TONGUE, BLISTERING OF MOUTH, TONGUE SENSATION LOSS OF, DIFFICULTY BREATHING, SPEECH DISORDER, SORE TONGUE, THROAT DISCOMFORT AND CHOKING TO BE RELATED TO POLIGRIP CUSHION COMFORT. ADDITIONAL INFORMATION:- THE ADVERSE EVENT INFORMATION WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 12-JUL-2021. THE REPORTER STATED THAT, "POLIGRIP I PURCHASED SOME OF YOU GUYS SUPER POLIGRIP CUSHION AND COMFORT AND I'M HAVING A BAD REACTION BEHIND IT, IT BREAKS MY TONGUE OUT, MY TONGUE GO SWELLING AND IT PUT BLISTERS IN MY MOUTH. WILL IT CAUSE ANY DAMAGE TO MY BODY IF I'M USING IT. IT DID IT 2 WEEKS AGO, I WENT TO **LOCATION REMOVED** MY TONGUE HAD SWELLED UP SO BIG, I HAD NO FEELING IN IT, AND I COULDN'T BREATHE AND TALK. SATURDAY I TRIED IT AGAIN AND IT DID THE SAME THING, MY TONGUE THE INSIDE OF MY MOUTH WAS BLISTERED UP AND SORE. IT HAS A BAD REACTION WITH ME, I CANT USE THIS. LOT 2023-08-06 LOT 184380, START (B)(6) ADVERSE EVENT START (B)(6), INDICATION LOOSE DENTURES, HEALTHCARE PROFESSIONAL ADVICE IF MY TONGUE DON'T GET ANY BETTER I WILL HAVE TO GO TO MY PRIMARY DOCTOR TO CHECK IT OUT, MY THROAT IT BOTHERS ME WHEN I SWALLOW, AT TIMES I FIND MYSELF CHOKING BECAUSE I CANT BREATHE GOOD BACK IN THERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142866 POLIGRIP CUSHION COMFORT DENTURE ADHESIVE KOT 184380

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 1) NO THERAPY (NO THERAPY)