BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANQUISH

    MDR report key: 12392069 · Received August 30, 2021

    Report

    Report Number
    MW5103599
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    August 26, 2021
    Report Date
    August 27, 2021
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A SECOND TREATMENT OF VANQUISH ME AT (B)(6). THE FIRST TREATMENT CAUSED SUCH SEVERE PAIN AND WAS TOLD IT WAS NORMAL BY SPA TECH. WENT FORWARD WITH SECOND TREATMENT AND I NOW HAVE A 'X' BURNED INTO MY ABDOMEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286105 VANQUISH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other