BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1047927 · Received May 15, 2008

    Report

    Report Number
    1022819-2008-00159
    Event Type
    Other
    Date Received
    May 15, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING DEVICE RETURN AND EVALUATION.

    Description of Event or Problem · 1

    PT RECEIVED A POTENTIAL BURN DURING AN ULTRASOUND PHYSICAL THERAPY TREATMENT. PT WAS BEING TREATED IN THE AREA OF THE GASTRO. THE TREATMENT PARAMETERS INCLUDED THE USE OF THE 5 CM SQUARED ULTRASOUND APPLICATOR WITH THE OUTPUT SETTING AT 1 TO 1.2 WATTS PER CENTIMETER SQUARED, 1 MHZ FREQUENCY, AND THE DUTY CYCLE SET TO 100%. WHEN THE CLINICIAN APPLIED THE APPLICATOR, THE PT COMPLAINED OF A BURNING SENSATION. THE CLINICIAN TERMINATED THE TREATMENT. THE PT DID NOT RECEIVE AN INJURY. THE PT HAD RECEIVED ULTRASOUND THERAPY PRIOR TO THE POTENTIAL INJURY INCIDENT. THE CLINICIAN NOTED THAT THE ULTRASOUND APPLICATOR GAVE NUMEROUS 'UNCOUPLED' INDICATIONS PRIOR TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS POWER MUSCLE STIMULATOR / ULTRASOUND THERAPY IPF CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other