BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANQUISH

    MDR report key: 5104081 · Received September 25, 2015

    Report

    Report Number
    3005028741-2015-00004
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    May 26, 2015
    Report Date
    September 25, 2015
    Manufacturer
    BTL INDUSTRIES LIMITED
    Product Code
    IMJ
    PMA / PMN Number
    K120093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BTL FOLLOWED UP WITH THE HEALTH CARE FACILITY TO GATHER ADDITIONAL INFORMATION. PER THE HEALTH CARE FACILITY PATIENT TOLERATED THE TREATMENT WELL. BURNS ARE LISTED IN THE OPERATOR´S MANUAL AS A POTENTIAL ADVERSE EFFECT. THE PATIENT'S INJURY IS HEALING WELL. THE SYSTEM LOGS WERE REVIEWED FOR THE TREATMENT DATES AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING THE TREATMENT DATES. 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 ABDOMEN EXPERIENCED SECOND DEGREE AND THIRD DEGREE BURNS IN THE TREATED AREA. PATIENT UNDERWENT A SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635728 VANQUISH SHORTWAVE DIATHERMY IMJ BTL INDUSTRIES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention