BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6995261 · Received November 1, 2017

    Report

    Report Number
    3008082710-2017-00047
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    June 10, 2017
    Report Date
    October 4, 2017
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT. ANALYSIS OF TREATMENT DATA RECORDED BY THE SYSTEM REVEALED NOTHING UNUSUAL. THERE WERE NO DEVICE PERFORMANCE OR USER ISSUES OBSERVED THAT WOULD CAUSE INFECTION.

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT. ANALYSIS OF TREATMENT DATA RECORDED BY THE SYSTEM REVEALED NOTHING UNUSUAL. THERE WERE NO DEVICE PERFORMANCE OR USER ISSUES OBSERVED THAT WOULD CAUSE INFECTION. (B)(4).

    Description of Event or Problem · 1

    PATIENT DEVELOPED NUMBNESS, TENDERNESS, AND TINGLING SENSATIONS IN THE RIGHT ARM (BICEPS TO THE ELBOW) AND BURN-LIKE MARKS (RESOLVED) IN BOTH AXILLAE. THE PHYSICIAN INJECTED STEROIDS IN THE AXILLAE (DATE UNKNOWN). THE PATIENT HAS TYPE I DIABETES AND KNOWN TO HAVE PROBLEMS WITH PERIPHERAL NEUROPATHIES.

    Description of Event or Problem · 1

    PATIENT DEVELOPED NUMBNESS, TENDERNESS, AND TINGLING SENSATIONS IN THE RIGHT ARM (BICEPS TO THE ELBOW) AND BURN-LIKE MARKS (RESOLVED) IN BOTH AXILLAE. THE PHYSICIAN INJECTED STEROIDS IN THE AXILLAE (DATE UNKNOWN). THE PATIENT HAS TYPE I DIABETES AND KNOWN TO HAVE PROBLEMS WITH PERIPHERAL NEUROPATHIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772990 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 16H2920 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention