BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5047992 · Received September 1, 2015

    Report

    Report Number
    3008082710-2015-00021
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    October 29, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 SPECIFICATIONS PRIOR TO SHIPMENT. MISSING INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED INSENSIBILITY (NUMBNESS) OF LEFT FINGERTIP AFTER HER MIRADRY TREATMENT (LATER INCLUDED BALL OF LEFT THUMB AND INDEX FINGER, THEN LATER OTHER FINGERS). REPORTED DIFFICULTY TO HOLD CHOPSTICKS. INITIALLY SHE ALSO NOTED BRUISING, SWELLING AND TENDERNESS IN BOTH AXILLA, NORMAL POST-TREATMENT SIDE EFFECTS THAT RESOLVED WITHIN TWO WEEKS. THERE WAS SOME SUPERFICIAL NUMBNESS IN THE UNDERSIDE OF UPPER LEFT ARM THAT TOOK LONGER TO GO AWAY. THE PHYSICIAN PRESCRIBED SEVERAL MEDICATIONS THAT ARE AVAILABLE IN (B)(4). PATIENT WAS FOLLOWED FOR APPROXIMATELY 6 MONTHS WITH SOME IMPROVEMENT NOTED. PATIENT HAS BEEN TRAVELLING ABROAD SO NO FURTHER UPDATES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577492 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 13H2076

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention