BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE CREAM

    MDR report key: 1396032 · Received May 27, 2009

    Report

    Report Number
    9681138-2009-00096
    Event Type
    Other
    Date Received
    May 27, 2009
    Report Date
    May 27, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WAS RECEIVED FROM THE CONSUMER ON 30 APRIL 2009. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THE PRODUCT IS KNOWN; HOWEVER, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF RECTAL BLEEDING IN A (B)(6) MALE PATIENT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED LACTULOSE. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED RECTAL BLEEDING, PHARMACEUTICAL PRODUCT COMPLAINT (OOZING), BLOATING, NUMBNESS IN HAND, NUMB FEET, NUMBNESS LOCALIZED (NECK), BLURRED VISION, HEADACHE, GREENISH STOOL, EATING DISORDER (COULDN'T EAT), CONSTIPATION, DIARRHEA, ZINC HIGH AND COPPER HIGH. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE CONSTIPATION, GREEN STOOL AND BEING UNABLE TO EAT CONTINUE. IT IS UNKNOWN IF THE ELEVATED ZINC AND COPPER LEVELS CONTINUE AND THE OTHER EVENTS HAVE RESOLVED. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BLOATING, NUMBNESS IN HANDS, FEET, AND NECK, BLURRED VISION, HEADACHES, GREEN STOOLS, COULDN'T EAT, CONSTIPATION, DIARRHEA, HIGH ZINC AND HIGH COPPER LEVELS, THE PRODUCT COMPLAINT OF OOZING AND RECTAL BLEEDING. CONSUMER THEN MENTIONED EVENT OF RECTAL BLEEDING. THE CONSUMER WAS UNAVAILABLE AT THIS TIME FOR FURTHER REPORT. THE CONSUMER REPORTED THE ADDITIONAL ADVERSE EVENTS OF: WEIGHT GAIN, LIVER PAIN AND KIDNEY PAIN. THE CONSUMER REPORTED THAT HER WENT FROM (B)(6) POUNDS IN THE FALL OF 2007 TO (B)(6) POUNDS IN (B)(6) 2009. HE ALSO REPORTED THAT HE WAS CONSTIPATED DUE TO HIS USE OF SUPER POLIGRIP. DUE TO THE CONSTIPATION, HIS PSYCHIATRIST PRESCRIBED LACTULOSE. THE PATIENT REPORTED THAT HE EXPERIENCED RECTAL PAIN, SEVERE GAS AND GAS PAIN, BUT HE ATTRIBUTED THOSE EVENTS TO THE USE OF LACTULOSE. THE CONSUMER ALSO RELATES THAT HE HAD BEEN USING SUPER POLIGRIP REGULARLY FROM (B)(6) 2008 THEN INTERMITTENTLY. HE REPORTS HIS DENTURES ARE TOO LARGE AND HE HAD TO REAPPLY. HE REPORTED THE PRODUCT COMPLAINT OF DID NOT HOLD. AT THE TIME OF THE REPORT, THE LIVER AND KIDNEY PAIN CONTINUE, THE OTHER EVENTS HAVE RESOLVED. THE CONSUMER HAS DISCONTINUED USING THE SUPER POLIGRIP. THE CONSUMER STATED THAT HE HAS CONSULTED [REDACTED], ATTORNEY AT LAW, (B)(4) ALTHOUGH HE REPORTS, HE DOES NOT INTEND TO PURSUE LEGAL ACTION. AE FOLLOW-UP INFORMATION RECEIVED VIA TELEPHONE (B)(6) 2009: CONSUMER REPORTED ADDITIONAL EVENTS OF ARM TINGLING, TINGLING FEET, SWELLING OF LEGS, FOOT SWELLING, CALVE SWELLING, SWELLING ALL OVER, FOOT PAIN, FELT POISONED, AND WEIGHT GAIN OF 5 POUNDS AND SWALLOWING TROUBLE. THE CONSUMER HAS DISCONTINUED USE OF SUPER POLIGRIP AND THE ABOVE EVENTS CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE R07451

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other VITAMIN D| BITAMIN B12 + FOLIC ACID| CRANBERRY AND URINARY HEALTH SUPPLEMENT| JOINT RELIEF SUPPLEMENT| DOCOSAHEXAENOIC ACID| PROSTATE HEALTH| XANAX| "CHOLESTOFF"| ATENOLOL| METHADONE HYDROCHLORIDE| MAGNESIUM SALT| HYDROCHLOROTHIAZIDE| ALPRAZOLAM