BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6008998 · Received October 6, 2016

    Report

    Report Number
    3008082710-2016-00064
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 2, 2016
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION IS BEING PURSUED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON RECEIPT OF ADDITIONAL INFORMATION AND/OR CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT E-MAILED MANUFACTURER DIRECTLY, REPORTING THE FOLLOWING: THE ISSUES THAT I AM HAVING ARE THE FOLLOWING: MY ARMPITS STILL LOOK SWOLLEN AND THEY NEVER WENT BACK TO THEIR NORMAL SIZE; MY ARMPITS LOOK GIANT AND I CANNOT WEAR A SLEEVELESS TOPS AS A RESULT OF IT. THERE ARE NUMEROUS LUMPS THAT GOT FORMED DURING THE TWO PROCEDURES THAT I HAD AND THEY NEVER DISAPPEARED. I ALSO BELIEVE THERE WAS A DAMAGE TO NERVES SINCE I DON'T FEEL ANYTHING WHEN I TOUCH SOME OF THE ARMPIT AREAS. I DEVELOPED FACIAL FLUSHING AFTER THE PROCEDURE SINCE I STOPPED SWEATING IN THE UPPER AREA OF MY BODY. ALSO, ALTHOUGH I WAS SWEATING HEAVILY PRIOR TO PROCEDURE, I WAS NEVER SMELLING BAD; HOWEVER, THAT CHANGED AFTER THE PROCEDURE. THE SWEATING IN THE ARMPIT AREA HAD STOPPED SINCE BUT I GOT THIS TERRIBLE SMELL THAT I CAN'T DEAL WITH DESPITE MY EFFORTS TO KEEP THE AREA CLEAN BY WASHING IT FIVE TO SIX TIMES A DAY AND APPLYING DIFFERENT DEODORANTS. I ALSO TRIED APPLYING HOMEMADE PRODUCTS BUT NOTHING WORKS. I WAS PATIENTLY WAITING FOR ALL THE SYMPTOMS TO GO AWAY ASSURING MYSELF THAT I NEED TO ALLOW SOME TIME, BUT THREE YEARS LATER THEY ARE STILL PRESENT. ABOUT SIX MONTHS AGO, I REQUESTED A FOLLOW UP PROCEDURE, BUT AFTER TALKING TO ME FOR NO MORE THAN 10 MINUTES, I WAS PRETTY MUCH RUSHED OUT OF THE OFFICE WITH EXPLANATION THAT THE ENLARGED AREA IS PROBABLY DUE TO A WEIGHT GAIN ALTHOUGH I DID NOT GAIN ANY WEIGHT; AS A MATTER OF FACT, I LOST SOME WEIGHT SINCE THE PROCEDURE. FOR THE RECORD, I AM (B)(6) TALL FEMALE WEIGHTING (B)(6) AT THE MOMENT. WHEN I ASKED ABOUT THE LUMPS, I GOT THE FOLLOWING ANSWER: "WHO CARES ABOUT THE LUMPS? THEY ARE NOT CANCEROUS". I ALSO MENTIONED THE OTHER SYMPTOMS, BUT I WAS TOLD THAT THEY HAVE NOTHING TO DO WITH MIRADRY PROCEDURE AND THAT I SHOULD PROBABLY SEE SOME ENDOCRINOLOGIST CONSIDERING MY AGE. AT THIS MOMENT, I DON'T HAVE ANY MEANS TO DEAL WITH THIS SITUATION AND I AM ASKING YOU TO HELP ME. CLINIC WAS CONTACTED AND REPORTED EFFORTS FOR FOLLOW-UP WERE UNSUCCESSFUL SINCE THE PHONE NUMBER PROVIDED BY THE PATIENT WAS NO LONGER VALID. ADDITIONAL INFORMATION FROM CLINIC'S PERSPECTIVE IS EXPECTED BUT HAS NOT BEEN RECEIVED. MANUFACTURER HAS REQUESTED PATIENT'S PERMISSION TO SUPPLY E-MAIL ADDRESS AND MESSAGE TO CLINIC. RESPONSE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656532 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 11H0454

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other