BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2549078 · Received April 18, 2012

    Report

    Report Number
    9681138-2012-00046
    Event Type
    Other
    Date Received
    April 18, 2012
    Report Date
    April 17, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SPEECH DISORDER IN A MALE PT WHO RECEIVED GSK DENTURE ADHESIVE (SUPER POLIGRIP-FORMULATION UNK) FOR DENTURE ADHESION. 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 SPEECH DISORDER, BALANCE DIFFICULTY, COORDINATION DISTURBANCE, DISABILITY AND MUSCLE WEAKNESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. AE INFO RECEIVED VIA MAIL 10 APRIL 2012: THIS CONSUMER REPORTS USING SUPER POLIGRIP AND EXPERIENCING PROBLEMS WITH SPEECH, BALANCE PROBLEMS, COORDINATION PROBLEMS AND LOSS OF MUSCLE STRENGTH IN ARMS. THE PT STATED THAT HE IS DISABLED AND HAS SOCIAL SECURITY DISABILITY. THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00046.

    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 Other