BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER POLIGRIP

    MDR report key: 2621289 · Received June 7, 2012

    Report

    Report Number
    9681138-2012-00063
    Event Type
    Death
    Date Received
    June 7, 2012
    Report Date
    June 6, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00063. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE, (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (WIDOW OF PATIENT) AND DESCRIBED THE OCCURRENCE OF LEUKEMIA IN A (B)(6) MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (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 GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED LEUKEMIA. TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS FATAL. THE PATIENT DIED FROM LEUKEMIA. AN AUTOPSY WAS NOT PERFORMED. CALLER BEGAN CALL INQUIRING ABOUT SOMETHING SHE HAD SEEN ON TV CONCERNING SUPER POLIGRIP AND ZINC. SHE REPORTED IT WAS A HEALTH WARNING AND NOT A LAWYER'S ADVERTISEMENT. SHE REPORTED THAT HER HUSBAND HAD BEEN USING SUPER POLIGRIP FOR MANY YEARS NOT EXCESSIVELY FOR HIS PARTIAL HOWEVER HE DEVELOPED LEUKEMIA AND PASSED AWAY AT (B)(6). SHE BELIEVED SUPER POLIGRIP PLAYED SOME ROLE. SHE WAS UNWILLING TO PROVIDE ANY INFORMATION UNTIL SHE SPOKE WITH HER ATTORNEY AND ASKED TO SPEAK WITH A SUPERVISOR. SHE DISCONNECTED THE CALL WHILE ON HOLD AS THE CALL WAS BEING PREPARED FOR TRANSFER.

    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 78 YR Death