BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 12870672 · Received November 24, 2021

    Report

    Report Number
    3008082710-2021-00016
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    June 5, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT FEELS NUMBNESS AND WEAKNESS ON HER FINGER. SHE FELT IT IMMEDIATE AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768534 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other