BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6108243 · Received November 16, 2016

    Report

    Report Number
    3008082710-2016-00065
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    February 13, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIRADRY CLINICS IN THE PATIENT'S DESCRIBED LOCATION WERE CONTACTED FOR POTENTIAL FOLLOW-UP. THERE WERE NO RECORDS MATCHING THE PATIENT'S TREATMENT DATE. IT IS UNKNOWN WHETHER THE PATIENT RECEIVED A MEDICAL DIAGNOSIS OF CYSTS. BUMPS UNDER THE TREATED AREA POTENTIALLY LASTING FOR SEVERAL MONTHS ARE A POTENTIAL SIDE EFFECT EXPECTED TO FULLY RESOLVE OVER TIME. HYPERPIGMENTATION WHICH IS EXPECTED TO RESOLVE OVER TIME MAY HAVE BEEN PERCEIVED AS SCARRING.

    Description of Event or Problem · 1

    PATIENT POSTED ON (B)(6) SITE REAL SELF 8 MONTHS POST TREATMENT: I WOULD NOT ADVISE GETTING THIS PROCEDURE. IT ONLY WORKS TEMPORARILY AND THEN EVERYTHING GOES BACK TO NORMAL AGAIN EXCEPT FOR THE DAMAGE IT LEAVES BEHIND I HAVE DEVELOPED CYSTS UNDER BOTH ARMPITS AFTER THIS PROCEDURE AND THEY HAVE SWELLED TO THE SIZE OF A NICKEL AND ARE PAINFUL. THE SWEAT NEVER FULLY GOES AWAY AND NEITHER DOES THE ODOR THE WAY THAT THEY SAY IT DOES, AND ONLY TELL YOU TO GET ANOTHER PROCEDURE DONE BUT I CANNOT WITH THIS SITUATION IT HAS CREATED AS WELL AS SOME SCARRING. MY UNDERARMS DON'T LOOK THE SAME ANYMORE COMMA THEY LOOK VERY MESSED UP COMPARED TO WHAT THEY WERE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757786 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other