BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER WERNETS

    MDR report key: 1914429 · Received November 19, 2010

    Report

    Report Number
    9681138-2010-00396
    Event Type
    Other
    Date Received
    November 19, 2010
    Report Date
    November 19, 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

    SUPER WERNETS DENTURE ADHESIVE POWDER IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE (LOT NUMBER N07484). IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DIABETES WORSENING IN A (B)(6) FEMALE PT WHO REC'D SUPER WERNETS DENTURE ADHESIVE POWDER ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER WERNETS DENTURE ADHESIVE POWER (DENTAL). AT AN UNK TIME AFTER STARTING SUPER WERNETS DENTURE ADHESIVE POWDER, THE PT EXPERIENCED DIABETES WORSENING AND INCREASED BLOOD SUGAR. THE PT ALSO REPORTED, "I HAVE HAD A COLD NOW FOR A WEEK". THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER WERNETS DENTURE ADHESIVE POWDER WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED THAT SUPER WERNETS MADE HER DIABETES WORSE. THE PT QUERIED IF THE PRODUCT CONTAINED SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER WERNETS DENTURE ADHESIVE POWDER KOL GLAXOSMITHKLINE N07484

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other