BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTRA GENISYS

    MDR report key: 1060936 · Received June 11, 2008

    Report

    Report Number
    1022819-2008-00170
    Event Type
    Other
    Date Received
    June 11, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 29, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVAL OF THE DEVICE.

    Description of Event or Problem · 1

    PT REC'D A 2ND DEGREE SKIN BURN DURING AN ELECTROTHERAPY TREATMENT. THE SKIN BURN LOCATION WAS IN THE AREA OF TREATMENT ON THE PT'S LOWER BACK. THE BURN MEASURED 1/2 INCH OR 1.2 CM IN DIAMETER. THE PT HAD REC'D ELECTROTHERAPY TREATMENT, WITHOUT INCIDENT, PRIOR TO THIS INCIDENT. THE PT IS EXPECTED TO MAKE A FULL RECOVERY FROM THE INJURY. CLINICIAN PRESCRIBED THE INTERFERENTIAL WAVEFORM FOR THE PT CONDITION. THE INTENSITY SETTING FOR THE OUTPUT WAS SET "TO PT TOLERANCE". THE TREATMENT TIME WAS 15 MINS. ALL OTHER TREATMENT SETTINGS OF THE DEVICE ARE UNDERSTOOD TO BE CONFIGURED TO THE FACTORY DEFAULT SETTINGS. THE TREATMENT TIME WAS 15 MINUTES. THE CLINICIAN ALSO PRESCRIBED ADJUNCTIVE HEAT THERAPY THAT WAS APPLIED OVER THE ELECTROTHERAPY TREATMENT AREA. THE CLINICIAN INSTRUCTED THE PT ON ADJUSTMENT OF THE OUTPUT INTENSITY OF THE THERAPY. THE PT COMPLETED THE 15 MINUTE TREATMENT. THE PT DID NOT INDICATE ANY DISCOMFORT AND/OR PAIN DURING OR POST TREATMENT. THE CLINICIAN DID NOT NOTE ANY INJURY OR REDNESS IN THE AREA OF TREATMENT. LATER THAT AFTERNOON, THE PT CONTACTED THE CLINIC TO INFORM THE CLINICIAN THAT THE BURN HAD APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2789

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other