BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2426274 · Received January 17, 2012

    Report

    Report Number
    9681138-2012-00014
    Event Type
    Other
    Date Received
    January 17, 2012
    Report Date
    January 16, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP 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 CONSUMER AND DESCRIBED THE OCCURRENCE OF BLISTERING OF MOUTH IN A FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (SUPER POLIGRIP) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK). AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PT EXPERIENCED BLISTERING OF MOUTH AND UNWELL. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2012, VIA A LEGAL COMPLAINT. THE PT EXPERIENCED HIGH ZINC, LOW COPPER, AND NEUROPATHY. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other