BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 7684194 · Received July 12, 2018

    Report

    Report Number
    3008082710-2018-00052
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    April 9, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MIRADRY, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NOTE: THE TREATING CLINIC DID NOT PROVIDE THE PHOTOS OF THE PATIENT'S TORSO TO MIRADRY, INC.

    Description of Event or Problem · 1

    PATIENT CONTACTED CLINIC 21 DAYS AFTER SUCCESSFUL MIRADRY TREATMENT IN AXILLA AND TRUNK (OFF-LABEL) WITH PHOTOS OF 2 SMALL ABSCESSES ON LEFT TORSO. THE TREATING CLINIC ADVISED THE PATIENT TO VISIT THE LOCAL HOSPITAL (B)(6). PATIENT FOLLOWED UP WITH THE CLINIC 3 DAYS LATER TO REPORT TREATMENT CONSISTED OF UNROOFING AND ANTIBIOTICS. THE PATIENT WAS HEALING. NO FURTHER FOLLOW-UP EXPECTED. PHYSICIAN STATED THE INJURY MAY HAVE BEEN CAUSED BY BLISTERS/BURN FROM THE POST-PROCEDURE ICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523181 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY, INC. MD4000-MC 16H1794

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention