BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP-UNIDENTIFIED

    MDR report key: 2329986 · Received November 4, 2011

    Report

    Report Number
    9681138-2011-00247
    Event Type
    Other
    Date Received
    November 4, 2011
    Report Date
    November 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

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

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A (B)(6) MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (SUPER POLIGRIP-UNIDENTIFIED) 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 ANEMIA. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS RESOLVED. CONSUMER STATED HE HAD BEEN USING SUPER POLIGRIP, VARIANTS UNKNOWN, FOR YEARS UNTIL HE STOPPED APPROXIMATELY A YEAR AND A HALF AGO FROM TIME OF REPORT AFTER HE HAD A BLOOD TEST AND WAS TOLD BY HIS PHYSICIAN THAT HE WAS ANEMIC. CONSUMER REPORTED THAT ANEMIA RESOLVED AFTER HE STOPPED USING SUPER POLIGRIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other