BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT MICROWAVE THERAPY

    MDR report key: 10867919 · Received November 18, 2020

    Report

    Report Number
    MW5097979
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 17, 2020
    Manufacturer
    EMBLATION LIMITED
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SWIFT MICROWAVE THERAPY WAS SUPPOSED TO TREAT THE WART BUT INSTEAD IT CAUSED ULCERATION/NECROSIS OF THE FINGERTIP AND NERVE DAMAGE. THE WART REMAINED THERE AFTER THE WOUND HEALED AND LOOKS EVEN WORSE THAN BEFORE TREATMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330350 SWIFT MICROWAVE THERAPY SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY EMBLATION LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other