BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 14743295 · Received June 20, 2022

    Report

    Report Number
    3008082710-2022-70021
    Event Type
    Injury
    Date Received
    June 20, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 20, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT DEVELOPED SCAR POST TREATMENT AND HAD TO BE PLACED ON ANTIBIOTICS. ON 6/8/2022, SCAR IS RESOLVING AFTER TWO ROUNDS OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628363 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 18 Female Required Intervention