BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANQUISH

    MDR report key: 5010695 · Received August 18, 2015

    Report

    Report Number
    3005028741-2015-00003
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BTL INDUSTRIES LIMITED
    Product Code
    IMJ
    PMA / PMN Number
    K120093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BTL INDUSTRIES FOLLOWED UP WITH THE PHYSICIAN´S OFFICE TO GATHER ADDITIONAL INFORMATION. BASED ON INFORMATION RECEIVED NO ERRORS OR DEVICE MALFUNCTION OCCURRED DURING THE TREATMENT. THE SYSTEM LOGS WERE REVIEWED FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING THE TREATMENT. BURNS ARE LISTED IN THE OPERATOR´S MANUAL AS A POTENTIAL ADVERSE EFFECT. THE PATIENT IS TREATED BY THE WOUND CARE SPECIALIST. AS OF (B)(6) 2015 THE INJURY IS NOT GETTING BETTER. A F/U REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT TREATED BY VANQUISH TO LOWER BACK COMPLAINED OF BURN IN THE TREATED AREA. PATIENT IS TREATED FOR WOUND WITH BURN COOLING PATCHES, BACITRACIN AND IBUPROFEN. PATIENT WAS SEEN BY URGENT CARE HOSPITAL. SHE WAS DIAGNOSED WITH 3RD DEGREE BURN. PATIENT WAS REFERRED TO WOUND CARE SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543965 VANQUISH SHORTWAVE DIATHERMY IMJ BTL INDUSTRIES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention