BEUDAMED
    FDA Adverse Event Summary report: N

    VERSEO EPEN

    MDR report key: 2434291 · Received January 21, 2012

    Report

    Report Number
    MW5024036
    Date Received
    January 21, 2012
    Date of Event
    December 13, 2011
    Report Date
    January 21, 2012
    Manufacturer
    SHARPER IMAGE
    Product Code
    KCX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER FOUR WEEKLY USES, THE FINGER I USED TO DEPRESS THE ACTIVATION BUTTON BEGAN TO LOSE SENSATION. THE TIP OF MY FINGER BECAME PAINFUL TO THE TOUCH, AND IT WAS DIFFICULT TO WRITE WITH A PEN. I WAS SUSPICIOUS THAT THIS DEVICE WAS THE CULPRIT. I TOOK A MULTIMETER AND MEASURED THE VOLTAGE AT THE ACTIVATION BUTTON AGAINST GROUND. IT MEASURED 12 VOLTS WHEN OPERATING! THIS VOLTAGE WAS EVEN HIGHER THAN THE VOLTAGE AT THE APPLICATION TIP! OBVIOUSLY THERE IS EITHER A MANUFACTURING DEFECT OR A SERIOUS DESIGN FLAW. I AM AN ELECTRICAL ENGINEER BY DEGREE, AND CAN TELL YOU THAT PROLONGED EXPOSURE OF 12 VOLTS TO THE SKIN IS HARMFUL. THIS ITEM SHOULD BE RECALLED. (B)(4). MANUFACTURER WEBSITE URL: SHARPERIMAGE.COM. PURCHASE DATE: (B)(6) 2011. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. I HAVE REPORTED THIS TO SHARPER IMAGER VIA "RATE THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSEO EPEN ELECTROLYSIS PEN KCX SHARPER IMAGE 100871-01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR