BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 15199394 · Received August 10, 2022

    Report

    Report Number
    3008082710-2022-70028
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    June 9, 2022
    Report Date
    August 10, 2022
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF CONSOLE DATA WAS COMPLETED ON 08/09/2022 AND INDICATED THAT THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 0

    PATIENT IS REPORTING NUMBNESS IN THEIR THUMB, INDEX AND MIDDLE FINGER OF THEIR RIGHT HAND SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606177 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 222 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other