BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER POLIGRIP

    MDR report key: 1983853 · Received February 5, 2011

    Report

    Report Number
    9681138-2011-00031
    Event Type
    Death
    Date Received
    February 5, 2011
    Report Date
    February 3, 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

    NO CONTACT INFORMATION WAS PROVIDED; THEREFORE, THIS CASE IS LOST TO FOLLOW-UP. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(6).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (DAUGHTER-IN-LAW OF PATIENT) AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN AN ELDERLY MALE PATIENT WHO RECEIVED SUPER POLIGRIP (FORMULATION UNKNOWN) (SUPER POLIGRIP) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED LEG NUMBNESS, LEG PAIN, FOOT PAIN, METAL POISONING, BEDRIDDEN, INABILITY TO SWALLOW, BLOOD CLOT IN LEG, LEG EDEMA, CANCER, DEVICE MISUSE BY USING ONE TUBE OF SUPER POLIGRIP PER WEEK, BACK PAIN, PARTIALLY BLIND AND POOR VISION. SUBSEQUENTLY, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. CONSUMER REPORTED THAT HER FATHER IN LAW JUST PASSED AWAY WITH A LOT OF THE SYMPTOMS THAT SHE HEARD ABOUT FOR SUPER POLIGRIP. SHE STATED THAT HE WAS USING A TUBE OF SUPER POLIGRIP A WEEK (DRUG MALADMINISTRATION). SHE STATED THAT HE HAD NUMBNESS AND PAIN IN HIS LOWER EXTREMITIES AND PAIN IN HIS FEET AND HIS LOWER BACK. SHE SAID, SHE ISN'T SURE IF HE HAD ZINC POISONING. SHE STATED THAT HE HAD CANCER IN HIS LOWER BACK AND WAS HOSPITALIZED AND HAD TO HAVE RADIATION AND CHEMOTHERAPY. SHE ALSO STATED THAT HE HAD A BLOOD CLOT IN HIS LEG AND ONE LEG WAS BIGGER THAN THE OTHER. SHE STATED THAT SHE IS NOT SURE IF THE EVENTS OF CANCER IN LOWER BACK, BLOOD CLOT IN LEG AND ONE LEG BEING BIGGER THAN THE OTHER ARE RELATED TO USE OF SUPER POLIGRIP. SHE STATED THAT WHEN HE CAME TO LIVE WITH THEM THAT HE WAS BED RIDDEN AND COULDN'T SWALLOW. SHE ALSO STATED THAT HE WAS HALF BLIND AND COULDN'T SEE WELL. SHE INDICATED THAT ALL OF THESE EVENTS OCCURRED WITHIN AN 8 MONTH SPAN AND HE THEN PASSED AWAY. CONSUMER REPORTED THAT HER FATHER IN LAW WAS (B)(6) WHEN HE PASSED AWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death