BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4895456 · Received July 7, 2015

    Report

    Report Number
    3008082710-2015-00010
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    April 29, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINIC REPORTED ADDITIONAL INFORMATION ON 01/11/2017.

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    PATIENT NOTICED AXILLARY SWELLING INCREASING APPROXIMATELY 4 WEEKS AFTER TREATMENT. WAS SEEN IN CLINIC 2 DAYS LATER WHEN BILATERAL CYSTS WERE EXAMINED, PROVIDED MINOCYCLINE. TWO DAYS LATER THE CYSTS ERUPTED WITH WARM WATER, LEAVING FOUL SMELLING DISCHARGE. WAS SEEN IN CLINIC AND AREA CULTURED. FOLLOW-UP IS ONGOING.

    Description of Event or Problem · 1

    PATIENT RECEIVED A DIAGNOSIS OF HIDRADENITIS SUPPURATIVA (HS) AND CONTINUED TO EXPERIENCE CYSTS. THE CLINIC WILL CONTINUE TO FOLLOW THE PATIENT FOR CHRONIC HS AND PRESCRIBING HUMIRA FOR SYMPTOM MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438711 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 12H0254

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention