BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4949787 · Received July 29, 2015

    Report

    Report Number
    3008082710-2015-00015
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    January 13, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. MISSING INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED PAIN AND LUMPS IN BOTH UNDERARMS, REPORTED 5 MONTHS AFTER TREATMENT. DIAGNOSED WITH ABSCESSES (APPROX 1 CM) AND DRAINED. PRESCRIBED ANTIBIOTICS AND STEROIDS. STATUS AS OF 1.5 MONTH POST DIAGNOSIS IS THAT PATIENT IS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493896 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention