BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2163587 · Received June 9, 2011

    Report

    Report Number
    9681138-2011-00140
    Event Type
    Other
    Date Received
    June 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOT LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NERVE DAMAGE IN A FEMALE PATIENT WHO USED POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING POLIGRIP. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED PERSONAL INJURIES, INCLUDING NEUROLOGICAL DAMAGES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 05/31/2011 VIA FACT SHEETS COMPLETED BY THE PATIENT AND/OR THE PATIENT'S ATTORNEY. THE PATIENT BEGAN RECEIVING DISABILITY PAYMENTS IN 2004 DUE TO "ILLNESS, BACK SURGERY, AND NEUROPATHY." IN 2005, THE PATIENT'S BLOOD PRESSURE WAS "GOING HIGH AND LOW" AND UNABLE TO BE CONTROLLED. THE PATIENT'S LEGS AND ARMS STARTED GETTING TIRED. IN 2006, THE PATIENT EXPERIENCED BLOOD LOSS AND ANEMIA. IN 2007, THE PATIENT'S LEGS AND MUSCLES STARTED "FEELING LIKE JELLO" AND HAVING DIFFICULTY WALKING. IN (B)(6) 2008, THE PATIENT WENT TO THE HOSPITAL BECAUSE SHE NEEDED "BLOOD VERY BADLY." THE BURNING, TINGLING, AND NUMBNESS IN LEGS, ARMS, AND HANDS WAS CAUSED BY NEUROPATHY AND BLOOD LOSS. THE PATIENT HAD CHRONIC FATIGUE IN LEGS AND GENERAL WEAKNESS. THE PATIENT DEPENDED ON HER HUSBAND FOR SUPPORT AND ASSISTANCE BECAUSE SHE FELT UNSTABLE AND BECAUSE OF THE SHAKINESS, NUMBNESS, WEAKNESS, AND FATIGUE IN HER LEGS. FROM (B)(6) 2008 UNTIL (B)(6) 2010, THE PATIENT WAS TREATED FOR SEVERE ANEMIA, LEUKOPENIA, COPPER DEFICIENCY, AND IRON DEFICIENCY. THE PATIENT FIRST USED UPPER AND LOWER DENTURES ON (B)(6) 2004. THE PATIENT USED SUPER POLIGRIP ORIGINAL FROM (B)(6) 2004 UNTIL THE TIME OF THIS REPORT, FIVE TO SIX TIMES A DAY, TWO 2.4 OUNCE AND FOUR 1.4 OUNCE TUBES PER WEEK. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability