BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 19174345 · Received April 24, 2024

    Report

    Report Number
    3008082710-2024-70007
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 24, 2024
    Manufacturer
    MIRADRY INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K1311162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ¿ COMPLAINT FROM PATIENT 1. FROM SHOULDER TO THE WRIST, SHE FEELS THE SENSATION OF WATER FLOWING. 2. WHEN SHE MAKES A DOWN POSITION OF HER ARM, FEELS TINGLING. HOWEVER, WHEN SHE RAISE HER ARM SHE DOES NOT FEEL TINGLING. 3. 1-2 MONTHS POST THE TREATMENT, SHE FELT SEVERE PAIN THROUGHOUT HER ARMS BUT IT WAS RESOLVED. SOMETIMES SHE FEELS SPONTANEOUS PAIN. ¿ ASSESSMENT BY DOCTOR 1. 09/MAY/23 : DOCTOR RECOMMENDED TO WAIT 6-12MONTHS 2. 03/MAR/24 : A DOCTOR WHO PERFORMED THE TREATMENT LEFT A CLINIC SO DR. KIM TOOK OVER THE PATIENT TO ASSESS. THERE WAS NO VISIBLE TIGHT BAND ON BOTH ARMS. PATIENT COMPLAINT ABOUT 2 SMALL NODULES ON RT. UNDERARM BUT DOCTOR COULD SEE BASED ON HIS ASSESSMENT. PATIENT STILL COMPLAINS ABOUT TINGLING SENSATION WHEN SHE DOWN HER BOTH ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942618 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other