BEUDAMED
    FDA Adverse Event Summary report: N

    SUPER POLIGRIP CREAM

    MDR report key: 2112477 · Received March 11, 2011

    Report

    Report Number
    9681138-2011-00066
    Date Received
    March 11, 2011
    Report Date
    March 10, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION FROM THE PT WAS RECEIVED ON (B)(6) 2011. THE PT ALSO REPORTED THAT SHE EXPERIENCED ZINC TOXICITY FROM USING SUPER POLIGRIP. THE PT DECLINED PERMISSION TO CONTACT HER PHYSICIAN. SUPER POLIGRIP IS MANUFACTURED IN DUNGARVAN, IRELAND AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. CASE (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROLOGICAL PROBLEM IN A FEMALE PT WHO RECEIVED SUPER POLIGRIP DENTURE ADHESIVE (FORMULATION (B)(4)) CREAM FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED POLIDENT (FORMULATION UNK). ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP DENTURE ADHESIVE (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP DENTURE ADHESIVE, THE PT EXPERIENCED NEUROLOGICAL PROBLEM, FEELING SICK, CONDITION AGGRAVATED, HEADACHE, TREMOR AND TROUBLE SPEAKING. THE PT WAS HOSPITALIZED. AT THE TIME OF REPORTING, THE EVENTS WERE WORSE. CONSUMER SAID SHE WAS USING POLIDENT AND "THE OTHER" AND HER SYMPTOMS HAD GOTTEN WORSE (CONDITION AGGRAVATED). SYMPTOMS ALSO INCLUDED FEELING SICK, HEADACHES, TREMOR AND NEUROLOGICAL PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization