BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 7862605 · Received September 10, 2018

    Report

    Report Number
    3008082710-2018-00092
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    May 18, 2018
    Report Date
    August 20, 2018
    Manufacturer
    MIRADRY, INC.
    Product Code
    OUB
    UDI-DI
    00853419006008
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT DEVELOPED LEFT AXILLARY ABSCESS ABOUT 12 DAYS POST MIRADRY TREATMENT. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED BUT AN INFECTION DEVELOPED, WHICH BECAME AN ABSCESS. THE ABSCESS WAS INCISED AND DRAINED ALONG WITH DRESSING CHANGES. TWO (2) ANTIBIOTICS WERE PRESCRIBED. THE INFECTION RESOLVED BUT RESULTED INTO A WOUND. BACITRACIN (TOPICAL ANTIBIOTIC) AND WOUND CARE WERE PRESCRIBED FOR 2 MONTHS BUT THE WOUND DID NOT HEAL. THE WOUND WAS CLEANED AND CLOSED BY THE TREATING CLINIC. ANOTHER SET OF ANTIBIOTICS WERE PRESCRIBED. UPDATE: BY 3.7 MONTHS POST-TREATMENT, THE CLINIC CONFIRMED THE INFECTION RESOLVED AND SUSPECTED THE SYMPTOMS WERE DUE TO HIDRADENITIS SUPPURATIVA. PATIENT WAS REFERRED TO A DERMATOLOGIST.

    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 RATE SEEN ((B)(4) WORLDWIDE INCIDENTS OUT OF ESTIMATED (B)(4) PROCEDURES PERFORMED TO DATE) IS APPROXIMATELY (B)(4)% OF THE PROCEDURES AND WITHIN THE ACCEPTABLE RANGE AS IDENTIFIED IN RISK ANALYSIS DOCUMENTATION.

    Description of Event or Problem · 1

    PATIENT DEVELOPED LEFT AXILLARY ABSCESS ABOUT 12 DAYS POST MIRADRY TREATMENT. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED BUT AN INFECTION DEVELOPED, WHICH BECAME AN ABSCESS. THE ABSCESS WAS INCISED AND DRAINED ALONG WITH DRESSING CHANGES. TWO (2) ANTIBIOTICS WERE PRESCRIBED. THE INFECTION RESOLVED BUT RESULTED INTO A WOUND. BACITRACIN (TOPICAL ANTIBIOTIC) AND WOUND CARE WERE PRESCRIBED FOR 2 MONTHS BUT THE WOUND DID NOT HEAL. THE WOUND WAS CLEANED AND CLOSED BY THE TREATING CLINIC. ANOTHER SET OF ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702316 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY, INC. MD4000-MC 16H1520 00853419006008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention