BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 12870664 · Received November 24, 2021

    Report

    Report Number
    3008082710-2021-00017
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    September 10, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD CHRONIC WOUNDS BILATERALLY ON AXILLAE. THE PATIENT WAS PRESCRIBED AMOXICILLIN AND BACTRIM. SHE HAS ALSO BEEN REFERRED TO INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768280 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention