BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6921209 · Received October 6, 2017

    Report

    Report Number
    3008082710-2017-00043
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 9, 2015
    Report Date
    April 14, 2017
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW 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. THE REPORT IS BEING FILED LATE DUE TO AN ISOLATED OVERSIGHT RESULTING FROM A PERSONNEL CHANGE.

    Description of Event or Problem · 1

    CLINIC REPORTED A PATIENT WITH 2-3 "PENNY-SIZED" NODULES IN EACH AXILLA 16 MONTHS POST MIRADRY TREATMENT. THE NODULES WERE PAINFUL TO THE TOUCH AND DURING EXERCISE (PLAYING VOLLEYBALL). STEROID INJECTIONS (KENALOG) WERE PRESCRIBED 2 YEARS POST TREATMENT. THE LAST FOLLOW-UP CONFIRMED THE PATIENT WAS BETTER AND HAS NOT RETURNED TO THE CLINIC FOR ADDITIONAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704554 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 15H0803

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention