BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER POLIGRIP (FORMULATION UNKNOWN)

    MDR report key: 2172684 · Received July 20, 2011

    Report

    Report Number
    9681138-2011-00177
    Event Type
    Death
    Date Received
    July 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(6), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (WIDOW OF PT) AND DESCRIBED THE OCCURRENCE OF MUSCULOSKELETAL DISORDER IN A (B)(6) YEAR-OLD MALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (SUPER POLIGRIP) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED MUSCULOSKELETAL DISORDER, WALKING DIFFICULTY, SKIN DISCOLORATION, POSSIBLE METAL POISONING AND DEATH OF UNK CAUSE. AT THE TIME OF REPORTING, THE EVENTS WERE FATAL. THE PT DIED FROM DEATH OF UNK CAUSE. AN AUTOPSY WAS NOT PERFORMED. AE INFORMATION RECEIVED VIA MAIL (B)(6) 2011: THE WIFE IS THE REPORTER REPORTING ON BEHALF OF HER DECEASED HUSBAND. THE REPORTER INDICATES THAT HER HUSBAND USED SUPER POLIGRIP SEVERAL TIMES PER DAY. SHE REPORTS THAT AS TIME WENT BY, HIS LEGS BECAME A MAJOR HEALTH PROBLEM AS HE COULD HARDLY WALK FROM ROOM TO ROOM AND THAT ONE OF HIS BIG TOES BECAME BLACK AND WAS ABOUT TO FALL OFF AT THE TIME OF HIS DEATH. THE REPORTER INDICATES IT IS ONLY NOW THAT SHE IS HEARING OF THE ZINC AND COPPER PROBLEMS ASSOCIATED WITH SUPER POLIGRIP. SHE GOES ON TO SAY THAT SHE KNOWS THAT THIS WAS MOST OF HIS LEG PROBLEMS AND THAT HER HUSBAND PASSED AWAY AT THE AGE OF (B)(6), BUT THAT HE HAD THE LEGS OF AN (B)(6) YEAR OLD. SHE STATES THAT SHE KNOWS THAT IT CANNOT BE PROVEN BECAUSE HE DID NOT HAVE THE BLOOD WORK DONE TO PROVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FORMULATION UNKNOWN) GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death