BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 3805334 · Received May 12, 2014

    Report

    Report Number
    3008082710-2014-00004
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K103014
    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 (INCLUDING STERILIZATION PROCESSING) WERE MET AND FOLLOWED. PRODUCT PASSED ALL REQUIRED TESTS AND INSPECTIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT HAD AN UNEVENTFUL MIRADRY TREATMENT. ON (B)(6) 2014, SHE WAS SEEN IN THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF SWELLING AND PAIN IN BOTH AXILLAE. THERE WERE MULTIPLE NODULES IN THE RIGHT AXILLA AND ONE LARGE NODULE IN THE LEFT AXILLA. THE NODULES WERE DRAINED AND THE PHYSICIAN PRESCRIBED AN ANTI-INFLAMMATORY, AN ANALGESIC, AND AN ANTIBIOTIC. ON (B)(6) 2014, THE PATIENT RETURNED TO THE OFFICE WITH NODULES STILL PRESENT. AN ANTI-INFLAMMATORY WAS INJECTED INTO THE AXILLAE. ON (B)(6) 2014, SHE WAS SEEN IN THE OFFICE AND WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283896 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 12H1744 (12H1659)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention