BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 15544491 · Received October 5, 2022

    Report

    Report Number
    3008082710-2022-70033
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 5, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    17 WEEKS POST-TX THE PATIENT IS EXPERIENCING A LARGE, LUMP BILATERALLY (THE RIGHT SIDE IS BIGGER) THEY STILL HAVE A "ZING" IN THEIR PINKY AND RING FINGER WHEN THEY MOVES THEIR ARM A CERTAIN WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592878 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention