BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6874906 · Received September 18, 2017

    Report

    Report Number
    3008082710-2017-00037
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 18, 2017
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. PRODUCTS MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    CLINIC REPORTED A PATIENT WITH BILATERAL ARM AND FINGER WEAKNESS 12 DAYS POST TREATMENT. PREDNISOLONE 2# BID AND VITAMIN B12 WERE PRESCRIBED. THE PHYSICIAN REFERRED THE PATIENT TO A NEUROLOGIST FOR EMG AND NCV EXAMS. THE RESULTS SHOWED MUSCLE WEAKNESS AND PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651514 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 14H0270

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability