BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 12659894 · Received October 19, 2021

    Report

    Report Number
    3008082710-2021-00014
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 19, 2021
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT REPORTED TWO RAISED LUMPS WITH TENDER INFLAMED SKIN. ON (B)(6) 2021, THE PATIENT REPORTED LESIONS OPENED UP LEAVING TWO OPEN WOUNDS. THE PATIENT WAS PRESCRIBED ANTIBIOTIC OINTMENT, CHLORHEXIDINE WASH TWICE A DAY, AND A WEEK COURSE OF DOXYCYCLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552306 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention