BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5016362 · Received August 19, 2015

    Report

    Report Number
    3008082710-2015-00017
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    May 3, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED A 2X3CM LUMP IN RIGHT UNDERARM TWO MONTHS AFTER TREATMENT. PHYSICIAN DRAINED PUS AND APPLIED ANTIBIOTIC OINTMENT. DIAGNOSED WITH INFECTION AND PRESCRIBED ANTIBIOTICS AND NSAID. STATUS AS OF ONE MONTH AFTER REPORT IS THERE WAS STILL A SMALL AMOUNT OF DRAINAGE BUT INFLAMMATION AND PAIN HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548119 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 12H0124

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention