BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 7060926 · Received November 27, 2017

    Report

    Report Number
    3008082710-2017-00048
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    January 6, 2017
    Report Date
    September 25, 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. THE REPORT IS FILED LATE DUE TO THE CLINIC DID NOT PROVIDE RELEVANT PATIENT INFORMATION UNTIL NOVEMBER 21, 2017.

    Description of Event or Problem · 1

    CLINIC REPORTED A PATIENT WHO DEVELOPED BILATERAL BURNS. THE LEFT AXILLA HAD A 2.5 CM DIAMETER FULL THICKNESS BURN, AND THE RIGHT AXILLA HAD 1 CM DIAMETER FULL THICKNESS BURN. THE PHYSICIAN STATED HE PULLED THE DEVICE OFF THE PATIENT EARLY AT EACH PLACEMENT AFTER 2 SECONDS OF THE POST-COOL TIME, WHICH ELIMINATED 18 SECONDS OF THE POST-COOL TIME. WOUND CARE, ORAL ANTIBIOTICS (SEPTRA), AND PHYSICAL THERAPY WERE PRESCRIBED. THE PATIENT CONFIRMED THE SYMPTOMS HEALED ABOUT 8 MONTHS POST-TREATMENT BUT BILATERAL SCARRING REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837684 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 12H1334 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention