BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIDERMA PRO RF

    MDR report key: 6732234 · Received July 19, 2017

    Report

    Report Number
    MW5071125
    Date Received
    July 19, 2017
    Date of Event
    June 26, 2017
    Report Date
    July 20, 2017
    Manufacturer
    MEDICREATIONS
    Product Code
    OUH
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DID A PRODUCT DEMONSTRATION WITH A NEW DEVICE CALLED MEDIDERMA PRO RF BY A COMPANY CALLED (B)(4). THE REP DID NOT HAVE MUCH KNOWLEDGE ABOUT THE PRODUCT, HAD STAFF TREAT EACH OTHER WITHOUT MUCH GUIDANCE. STAFF HAD MARKINGS ON THEIR FACE FOR AT LEAST 2 WEEKS. FOUND OUT DEVICE WAS NOT FDA CLEARED YET THE REP IS ACTIVELY PROMOTING, TAKING ORDERS AND DEMONSTRATING THE DEVICE WITHOUT PROPER CLEARANCES. "HOW WAS IT TAKEN OR USED: SUBCUTANEOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505184 MEDIDERMA PRO RF SKIN RESURFACTING RF APPLICATOR OUH MEDICREATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other