BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER STRENGTH POLIGARD

    MDR report key: 1820814 · Received August 27, 2010

    Report

    Report Number
    MW5017249
    Event Type
    Injury
    Date Received
    August 27, 2010
    Product Code
    KOL
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED SUPER POLIGRIP FROM 2008 UNTIL (B)(6)2010. I KEEP FEELING MY LEG AND FOOT ALWAYS WAS WEAK NUMBNESS AND TINGLING. SO I HAD A TEST DONE AT THE PAIN CLINIC AND MY NEXT VISIT WAS WHEN I WAS DIAGNOSED WITH NEUROPATHY, BUT THERE WERE REDSPOTS IN MY LEGS. I USED SUPER POLIGRIP FOR ABOUT 2 YRS. IT JUST HAD TO KEEP USING IT. I WAS LIKE IT MADE MY MOUTH UNCOMFORTABLE. THEN MY LEG AND FEET GIVE ME A HARD TIME ON MY LEFT SIDE BUT THEN MOVED TO MY RIGHT SIDE. THAT IS WHEN THE TINGLING AND NUMBNESS FROM THE TOP OF MY ARM DOWN TO MY FINGER TIPS AND WHOLE HAND WOULD BEGIN JUST TINGLING AND NOBBING FOR ABOUT 30 MINUTES AND A BREAK FOR A MINUTE, BUT THEN START BACK. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 2X DAILY, ROUTE: ORAL. DIAGNOSIS OR REASON FOR USE: DENTURE CREAM. EVENT ABATED AFTER USE: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER STRENGTH POLIGARD NONE KOL TUS1605B
    2 SUPER STRENGTH POLIGRIP NONE KOL 98294XB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S