BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5018648 · Received August 20, 2015

    Report

    Report Number
    3008082710-2015-00018
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 SORE, RED AREA IN LEFT UNDERARM 10 DAYS AFTER TREATMENT. PHYSICIAN DIAGNOSED AN ABSCESS AND DRAINED IT, PRESCRIBED ANTIBIOTICS. A FOLLOW-UP CHECK CONFIRMED THE PATIENT WAS GETTING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552328 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 14H2271

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention