BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6961962 · Received October 19, 2017

    Report

    Report Number
    3008082710-2017-00046
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    January 31, 2017
    Report Date
    September 25, 2017
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES DURING THE DISPOSABLE DEVICE MANUFACTURING, INCLUDING STERILIZATION. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT. AGE/DATE OF BIRTH AND SEX REQUESTED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN AND TINGLING SENSATIONS 1 DAY POST MIRADRY TREATMENT. THE PATIENT RECALLED "PINS AND NEEDLES FEELING" DOWN THE RIGHT ARM TO FINGERTIPS DURING THE TREATMENT. BOTH ARMS CONTINUED TO HAVE PAIN AND TINGLING SENSATIONS 9 MONTHS POST TREATMENT. THE PAIN AND TINGLING SENSATIONS HAD SPREAD TO THE BREAST TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741469 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 13H2516

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention