BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    MIRADRY SYSTEM

    MDR report key: 14336670 · Received May 9, 2022

    Report

    Report Number
    3008082710-2022-70014
    Event Type
    Injury
    Date Received
    May 9, 2022
    Report Date
    May 3, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A CASE OF HIDRADENITIS SUPPURATIVA THAT REQUIRED THE REMOVAL OF THE SWEAT GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552701 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention