BEUDAMED
    FDA Adverse Event Other Summary report: N

    (SUPER) POLIGRIP (FORMULATION UNK)

    MDR report key: 1622221 · Received February 26, 2010

    Report

    Report Number
    9681138-2010-00065
    Event Type
    Other
    Date Received
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURENCE OF POLYNEUROPATHY IN A (B)(6) PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (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) (UNK DOSING REGIMEN). AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PT EXPERIENCED POLYNEUROPATHY, FOOT PAIN AND INABILITY TO WALK. THE PT ALSO REPORTED THEY RECENTLY LOST THEIR JOB. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. MFR'S COMMENT: SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other