BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    MIRADRY SYSTEM

    MDR report key: 13996183 · Received April 4, 2022

    Report

    Report Number
    3008082710-2022-70008
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 4, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    PATIENT REQUIRED STEROIDS FOR EXCESSIVE SWELLING TWO WEEKS POST TREATMENT. THE ISSUE RESOLVED AFTER STEROIDS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619458 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention