BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4913270 · Received July 14, 2015

    Report

    Report Number
    3008082710-2015-00011
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTACTED PHYSICIAN REGARDING THE RAMIFICATION OF OFF-LABEL USE, AND REITERATED THE INFORMATION IN TRAINING MATERIALS AND LABELING AGAINST USE OF THE DEVICE EXCEPT IN THE UNDERARMS. PHYSICIAN HAS NOT BEEN COOPERATIVE.

    Description of Event or Problem · 1

    PATIENT CONTACTED MANUFACTURER TO REPORT SIGNIFICANT BLISTERING AND NERVE EFFECTS WHEN FOREIGN PHYSICIAN USED THE MIRADRY DEVICE TO TREAT HIS EXCESSIVE SWEATING ON HIS HANDS. MIRADRY IS ONLY TO BE USED TO TREAT UNDERARMS. OTHER DEVICES BESIDES MIRADRY MAY HAVE BEEN USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456952 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS INC. MD4000-MC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention