BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4925519 · Received July 20, 2015

    Report

    Report Number
    3008082710-2015-00012
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    December 1, 2014
    Report Date
    June 15, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT. PATIENT SYMPTOMS HAVE RESOLVED.

    Description of Event or Problem · 1

    PATIENT CONTACTED THE CLINIC WITH MULTIPLE SMALL BOILS APPROXIMATELY 6 MONTHS AFTER FINISHING MIRADRY TREATMENTS. PATIENT WAS IN A DIFFERENT CITY AND SAW A DIFFERENT DERMATOLOGIST. RESULT WAS DIAGNOSIS OF HIDRADENITIS SUPPURATIVA, UNRELATED TO MIRADRY TREATMENT. WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468233 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 11H0458

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention