BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE CREAM

    MDR report key: 1790950 · Received August 4, 2010

    Report

    Report Number
    9681138-2010-00280
    Event Type
    Other
    Date Received
    August 4, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PATIENT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) 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 NEUROPATHY, NUMBNESS OF UPPER EXTREMITIES AND NUMBNESS IN HAND. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2010-00280. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS KNOWN; HOWEVER IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE R09333

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other