BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIPATCH

    MDR report key: 5553878 · Received April 4, 2016

    Report

    Report Number
    MW5061532
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 4, 2016
    Manufacturer
    BIOELECTRONICS
    Product Code
    ILX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BIOELECTRONICS HAS NOT BEEN CLEARED TO SELL THEIR PRODUCTS OVER THE COUNTER IN THE USA. HOWEVER, THEY HAVE TWO SITES OVERSEAS SELLING AND SHIPPING BACK TO THE USA. AT CHECKOUT, THEY CONFIRM YOU CAN BUY IN THE USA. AND THEY ARE PROMOTING ONLINE TO DRIVE SALES TO THEM. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202146 ACTIPATCH ACTIPATCH ILX BIOELECTRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other