BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6111594 · Received November 17, 2016

    Report

    Report Number
    3008082710-2016-00066
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    June 1, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION PROVIDED. AN E-MAIL REPLY WAS SENT TO THE PATIENT WITH REQUEST FOR ADDITIONAL INFORMATION. NO REPLY HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    PATIENT REPORTED THE FOLLOWING INFORMATION VIA EMAIL: I HAD THIS PROCEDURE DONE BACK A YEAR AGO, IN (B)(6) 2015 I AM HAVING VERY A LOT OF PROBLEMS SO FAR. SINCE I HAVE HAD IT DONE I HAVE HAD SEVERAL ABSCESS REMOVED FROM BOTH ARMPITS I BELIEVE THE TOTAL OF 12 WITHIN THE YEAR AND I'M VERY DISCOURAGED BECAUSE IT ALSO HAS STARTED TO SWEAT AGAIN AND SMELL. PLEASE CONTACT ME I NEED TO TALK TO SOMEBODY ABOUT THIS I DON'T KNOW IF THIS IS NORMAL AND I'M GETTING TIRED OF GETTING BUTCHERED UNDER THE KNIFE TO REMOVE THESE ABSCESS. BUT YOU'RE ALSO COSTING ME EXTRA COST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761127 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention