BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D ARSENVAL

    MDR report key: 1317551 · Received February 13, 2009

    Report

    Report Number
    MW5010028
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    November 28, 2008
    Report Date
    February 13, 2009
    Manufacturer
    SKINRECHARGE LLC
    Product Code
    IRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE TRANSLATION OF INSTRUCTIONS FOR USE WERE WRITTEN BY A NON-MEDICAL PERSON. THE FACE SCULPTOR DID NOT WORK AND HAD NO RESULTS. IT WAS SUPPOSED TO TONE FACIAL MUSCLES, HELP WITH BLOOD CIRCULATIONS, FIRM SKIN. D ARSENVAL PROFESSIONAL WAS SUPPOSED TO HELP WITH HEMORRHOIDS, HELP WITH BLOOD CIRCULATIONS, HELP WITH COUGHS, CAUSED RED SPOTS, HELP WITH HAIR LOSS, INCREASES HEART RATE AND HELP WITH HEADACHES. IT HAS FRAGILE GLASS TIPS. DISTRIBUTOR'S INSTRUCTIONS WERE TO JUST LEAVE THE GLASS TIPS IN THE ELECTRIC HANDLE, AS THEY WERE EXPERIENCING SIMILAR TIP BREAKAGE PROBLEMS WITH OTHER UNITS. VIBRONETIKS PLATFORM AGGRAVATED LIVER PROBLEMS, DOUBLED KNEE PROBLEMS, INCREASED ARRYTHMIA PROBLEMS, WAS TO INCREASE BLOOD FLOW/CIRCULATION BY LOOSING THE MATERIALS ON ATRIAL WALLS, INCREASE OXYGEN FLOW. DATES OF USE: 2008 - 2009. DIAGNOSIS: 1. TONE MUSCLES, HELP WITH BLOOD CIRCULATIONS, FIRM SKIN. 2. HELP WITH HEMORRHOIDS, HELP WITH BLOOD CIRCULATIONS, HELP WITH. THE FACE SCULPTOR ARRIVED IN LATE 2008. THE BOXES FACTORY SEALS WERE BROKEN WHEN THEY ARRIVED, INDICATING THAT THEY HAD BEEN OPENED BEFORE SHIPMENT TO ME. WHEN I ASKED THEM ABOUT THIS, THEY SAID IT WAS BECAUSE THEY NEEDED TO INSPECT THE UNITS CHECK AND SEE IF THE BATTERIES WERE LEAKING. THE ONES SHIPPED TO ME ARRIVED WITHOUT BATTERIES. THE FACE SCULPTOR WAS RETURNED TO THEM IN EARLY 2009. THE D ARSENVAL UNIT - I HAD ALREADY SENT THEM THE BROKEN UNIT. THEY HAD SENT ME A REPLACEMENT FOR THE BROKEN GLASS PART IN LATE 2008 AND, AT NO ADDITIONAL COST, A SECOND ELECTRIC HANDLE. THEIR INSTRUCTIONS WERE TO JUST LEAVE THE GLASS TIPS IN THE ELECTRIC HANDLE, AS THEY WERE EXPERIENCING SIMILAR BREAKAGE PROBLEMS WITH OTHER UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D ARSENVAL FACE SCULPTOR IRO SKINRECHARGE LLC
    2 D ARSENVAL PROFESSIONAL VIBRONETIKS IRO SKINRECHARGE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR