BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    MIRADRY SYSTEM

    MDR report key: 14453619 · Received May 20, 2022

    Report

    Report Number
    3008082710-2022-70016
    Event Type
    Injury
    Date Received
    May 20, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THOUGH THE TREATMENT OF THE BURN IS NOT KNOWN, A REVIEW OF TREATMENTS IN (B)(6) 2022 SHOWED NO ISSUES WITH THE SYSTEM. THE SYSTEM APPEARS TO BE FUNCTIONING NORMALLY.

    Description of Event or Problem · 0

    THE TREATING PHYSICIAN REACHED OUT TO REPORT A PATIENT THAT DEVELOPED A FULL THICKNESS BURN A FEW DAYS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964995 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention