BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (ORIGINAL AND UNKNOWN)

    MDR report key: 1912822 · Received November 4, 2010

    Report

    Report Number
    9681138-2010-00376
    Event Type
    Other
    Date Received
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # UNK. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP ORIGINAL IS KNOWN WHILE THE LOT NUMBER FOR THE UNKNOWN FORMULATION OF SUPER POLIGRIP IS NOT AVAILABLE. IT IS UNKNOWN WHETHER THE PRODUCTS WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (DAUGHTER OF PATIENT) AND DESCRIBED THE OCCURRENCE OF LOSS OF SMELL IN A (B)(6) FEMALE PATIENT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) AND SUPER POLIGRIP (FORMULATION UNKNOWN) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE(S), THE PATIENT STARTED THE FORMULATIONS OF SUPER POLIGRIP. EIGHT YEARS AFTER STARTING SUPER POLIGRIP ORIGINAL AND FIVE YEARS AFTER STARTING SUPER POLIGRIP (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED LOSS OF SMELL. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH THE FORMULATIONS OF SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. CONSUMER'S DAUGHTER REPORTED THAT HER MOTHER HAS USED SUPER POLIGRIP ORIGINAL FOR 8 YEARS AND SUPER POLIGRIP (FORMULATION UNKNOWN) 5 YEARS PRIOR TO THE REPORT OF HER LOOSING HER SENSE OF SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (ORIGINAL AND UNKNOWN) DENTURE ADHESIVE (CREAM AND UNKNOWN) KOL GLAXOSMITHKLINE R10145

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other