BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 6691987 · Received July 6, 2017

    Report

    Report Number
    3008082710-2017-00021
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    March 9, 2013
    Report Date
    June 10, 2017
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. UPDATE: CHANGED OUTCOME ATTRIBUTED TO ADVERSE EVENT FROM "REQUIRED INTERVENTION . " TO "DISABILITY OR PERMANENT DAMAGE." ADD THE FOLLOWING STATEMENT TO DESCRIBE EVENT OR PROBLEM: INPUT FROM THE MIRADRY CONSULTING MEDICAL DIRECTOR INDICATED A SPECIAL TYPE OF BURN SCAR CAN LEAVE BLUE COLOR. NERVE DEFICITS PRESENT AFTER FOUR YEARS ARE LIKELY PERMANENT. THIS IS AN ISOLATED CASE WITH NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED APPROXIMATELY 5 LINGERING LARGE, BLUE DISCOLORED NODULES WITH NUMBNESS IN BOTH AXILLA SINCE HER SECOND MIRADRY TREATMENT 4 YEARS AGO. THE TREATING CLINIC HAD ADVISED HER THE SIDE EFFECTS SEEMED NORMAL AND SHOULD GO AWAY. UPDATE: INPUT FROM THE MIRADRY CONSULTING MEDICAL DIRECTOR INDICATED A SPECIAL TYPE OF BURN SCAR CAN LEAVE BLUE COLOR. NERVE DEFICITS PRESENT AFTER FOUR YEARS ARE LIKELY PERMANENT. THIS IS AN ISOLATED CASE WITH NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT REPORTED APPROXIMATELY 5 LINGERING LARGE, BLUE DISCOLORED NODULES WITH NUMBNESS IN BOTH AXILLA SINCE HER SECOND MIRADRY TREATMENT 4 YEARS AGO. THE TREATING CLINIC HAD ADVISED HER THE SIDE EFFECTS SEEMED NORMAL AND SHOULD GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472078 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 12H0049

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention| S