BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP

    MDR report key: 855071 · Received May 23, 2007

    Report

    Report Number
    MW5001930
    Event Type
    Injury
    Date Received
    May 23, 2007
    Report Date
    May 23, 2007
    Manufacturer
    SUPER POLIGRIP GLAXO SMITH KLINE CONSUMER HEALTHCARE LP
    Product Code
    KOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS TOTALLY DISABLED. HE WAS DIAGNOSED WITH NEUROPATHY 2 YEARS AGO AND TREATED WITH MEDICINE. HE HAS NO FEELING IN HIS HANDS AND IS USING WALKER TO KEEP FROM FALLING. HE SAID, HE DETERIORATED AFTER USING THIS DEVICE. HE HAS PAIN WHILE STANDING OR SITTING. HE SAID, HE HAS LOST HIS SHORT-TERM MEMORY AND HE CAN'T RECALL MANY THINGS. HE SAID MY LIFE IS DONE, AND PEOPLE THINK THAT I AM CONTAGIOUS AND THEY DON'T WANT TO COME TO SEE ME. I STILL CAN DRIVE, BUT I TAKE MY DAUGHTER WITH ME IN CASE I FALL. I HAVE FALLEN MANY TIMES BEFORE. HE SAID THAT, HE HAS READ AN ARTICLE ABOUT HIS PROBLEM, THAT 25% OF PEOPLE DIE FROM THAT EACH YEAR. HE SAID HE IS GOING TO GET AN ATTORNEY TO LOOK AT THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP NONE KOM SUPER POLIGRIP GLAXO SMITH KLINE CONSUMER HEALTHCARE LP
    2 SUPER POLIGRIP NONE KOM SUPER POLIGRIP GLAXO SMITH KLINE CONSUMER HEALTHCARE LP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR SOMA - 350MG| LACTASE| PAIN KILLER| NORTRIPTYLINE| DIAZEPAM - 10MG| MS - CONTIN / MORFINE 60MG| CYMBALTA