BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA)

    MDR report key: 8611490 · Received May 15, 2019

    Report

    Report Number
    3003721894-2019-00116
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    March 15, 2019
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE (B)(4).

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF RENAL STONE IN A 68-YEAR-OLD MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA)) CREAM (BATCH NUMBER EK4R, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA), THE PATIENT EXPERIENCED RENAL STONE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND INDIGESTION. THE ACTION TAKEN WITH SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE RENAL STONE, ACCIDENTAL DEVICE INGESTION AND INDIGESTION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE RENAL STONE, ACCIDENTAL DEVICE INGESTION AND INDIGESTION TO BE RELATED TO SUPER POLIGRIP ULTRA FRESH (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 MARCH 2019. THE CONSUMER REPORTED THAT, "SOME TIME WHEN I PUT THE SUPER POLIGRIP ON IT STICK TO THE ROOF OF MY MOUTH AND OTHER TIMES , THERE IS NOTHING THERE. SO I DON'T KNOW IF I'M SWALLOWING IT OR NOT WHAT'S GOING ON? I HAVE THE SUPER POLIGRIP ULTRA FRESH, THE LOT LOOKS LIKE EX48. IT'S EK4R. WHEN I DON'T EAT A LOT ALL DAY, IT'S THERE ,BUT WHAT I EAT IT NOT THERE. I TAKE THEM OUT EVER NIGHT AND SOAK THEM IN THE POLIDENT OVERNIGHT. I DON'T KNOW WHERE IS GOES. MAYBE THAT'S WHY I HAVE KIDNEY STONES. I DON'T THINK THAT'S SAFETY. I DON'T THINK IT'S SAFE I THINK IT'S CAUSING INDIGESTION.' FOLLOW UP ADVERSE EVENT INFORMATION WAS RECEIVED VIA AUTHORIZATION FORM ON 17 APRIL 2019. CONSUMER PROVIDED PHYSICIANS DETAILS. THE TWO LOT NUMBER (98099XI, 62000000007695) FOR SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA) WAS ADDED INTO THE CASE. FOLLOW UP INFORMATION WAS RECEIVED ON 11 JUNE 2019 VIA ADVERSE EVENT REPORTING (AER) FORM BY PHYSICIAN. PHYSICIAN MEDICALLY CONFIRMED THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    MAYBE THAT'S WHY I HAVE KIDNEY STONES [RENAL STONE], SO I DON'T KNOW IF I'M SWALLOWING IT OR NOT WHAT'S GOING ON? [ACCIDENTAL DEVICE INGESTION], I DON'T THINK IT'S SAFE I THINK IT'S CAUSING INDIGESTION [INDIGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF RENAL STONE IN A (B)(6) MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA)) CREAM (BATCH NUMBER EK4R, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA), THE PATIENT EXPERIENCED RENAL STONE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND INDIGESTION. THE ACTION TAKEN WITH SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE RENAL STONE, ACCIDENTAL DEVICE INGESTION AND INDIGESTION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE RENAL STONE, ACCIDENTAL DEVICE INGESTION AND INDIGESTION TO BE RELATED TO SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA). ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON 15 MARCH 2019. THE CONSUMER REPORTED THAT, "SOME TIME WHEN I PUT THE SUPER POLIGRIP ON IT STICK TO THE ROOF OF MY MOUTH AND OTHER TIMES , THERE IS NOTHING THERE. SO I DON'T KNOW IF I'M SWALLOWING IT OR NOT WHAT'S GOING ON? I HAVE THE SUPER POLIGRIP ULTRA FRESH, THE LOT LOOKS LIKE EX48. IT'S EK4R. WHEN I DON'T EAT A LOT ALL DAY, IT'S THERE ,BUT WHAT I EAT IT NOT THERE. I TAKE THEM OUT EVER NIGHT AND SOAK THEM IN THE POLIDENT OVERNIGHT. I DON'T KNOW WHERE IS GOES. MAYBE THAT'S WHY I HAVE KIDNEY STONES. I DON'T THINK THAT'S SAFETY. I DON'T THINK IT'S SAFE I THINK IT'S CAUSING INDIGESTION.' FOLLOW UP ADVERSE EVENT INFORMATION WAS RECEIVED VIA AUTHORIZATION FORM ON 17 APRIL 2019. CONSUMER PROVIDED PHYSICIANS DETAILS. THE TWO LOT NUMBER (98099XI, 62000000007695) FOR SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA) WAS ADDED INTO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406250 SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA) DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD 62000000007695

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other