BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP ORIGINAL AND SUPER POLIGRIP

    MDR report key: 2010795 · Received February 2, 2010

    Report

    Report Number
    9681138-2011-00027
    Event Type
    Other
    Date Received
    February 2, 2010
    Report Date
    February 2, 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

    ADDITIONAL LOT NUMBER: UNK. POLIGRIP VARIANTS ARE MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCTS NOR LOT NUMBERS FOR THESE PRODUCTS ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA FDA MEDWATCH PROGRAM (B)(4) ON (B)(6) 2011. FOLLOW-UP WAS RECEIVED FROM THE PATIENT ON (B)(6) 2011. THE PATIENT SAID SHE HAD TO ENDURE HER SYMPTOMS FOR THE LAST 10 YEARS, WITH THE LAST FIVE YEARS BEING VERY PAINFUL. THE PATIENT STATED THAT AFTER PRAYER AND FASTING SHE FEELS MUCH BETTER. THE PATIENT SAID THAT SHE HAD ENDURED PHYSICAL AND MENTAL PAIN DUE TO USE OF SUPER POLIGRIP. SHE SAID THAT SHE HAD UNDERGONE MULTIPLE DIAGNOSTIC TESTS INCLUDING THE FOLLOWING THAT WERE PERFORMED ON (B)(6) 2009: COMPLETE BLOOD COUNT WITH DIFFERENTIAL, URINALYSIS, COMPLETE METABOLIC PANEL, URIC ACID, LIPID, THYROID STIMULATING HORMONE AND KNEE RADIOGRAPHS. THE PATIENT WAS DIAGNOSED WITH JOINT PAIN, ARTHRITIS AND FATIGUE. CURRENTLY THE PATIENT IS (B)(6). THE PATIENT WAS IN HER (B)(6) AT THE ONSET OF SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability