BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5001742 · Received August 13, 2015

    Report

    Report Number
    3008082710-2015-00016
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    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. MISSING INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT .

    Description of Event or Problem · 1

    PATIENT DEVELOPED PAIN AND DISCOMFORT IN RIGHT UNDERARM ONE WEEK AFTER TREATMENT. DIAGNOSED WITH ABSCESS AND PRESCRIBED ANTIBIOTICS AND PAIN MEDICATION; ALSO WAS DRAINED. STATUS AS OF REPORT IS HEALING AND PAIN HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536829 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 13H0704

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention