BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2011786 · Received February 22, 2011

    Report

    Report Number
    9681138-2011-00050
    Event Type
    Other
    Date Received
    February 22, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A FEMALE PT WHO USED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. IN (B)(6) 2007, THE PT BEGAN USING SUPER POLIGRIP ORIGINAL AND FIXODENT. AN UNK TIME LATER, THE PT EXPERIENCED "HYPOCUPREMIA AND NEUROLOGIC DISEASE, RESULTING IN LOSS OF BALANCE, DIZZINESS, ANEMIA, WEAKNESS AND PAIN IN LEGS, BURNING SENSATION, NUMBNESS AND TINGLING IN HIS FEET." THIS CASE WAS CONSIDERED MEDICALLY SERIOUS BY GSK. FIXODENT WAS DISCONTINUED IN (B)(6) 2009, AND SUPER POLIGRIP ORIGINAL WAS CONTINUED. ACCORDING TO THE CLAIM, THE EVENTS WERE SEVERE AND PERMANENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other