BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEL ULTRA III

    MDR report key: 2196830 · Received August 1, 2011

    Report

    Report Number
    MW5021643
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 1, 2011
    Manufacturer
    EXCEL TECH LTD.
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXCEL ULTRA III E-STIM UNIT WAS APPLIED USING 4 ELECTRODES TO PT'S RIGHT SHOULDER IN THERAPY TREATMENT. APPROX 5 MINUTES INTO THE SESSION, THE PT REPORTED THE UNIT SUDDENLY STOPPING. PT DID NOT REPORT ANY OTHER UNUSUAL EVENT AT THAT TIME. ELECTRODE CONTACT WAS CHECKED AND TREATMENT WAS RESUMED FOR 10 MINUTES WITHOUT OTHER INCIDENT. ON (B)(6) 2011, PT PRESENTED FOR ANOTHER THERAPY SESSION. IT WAS REPORTED AT THAT TIME THAT "BURNS" APPEARED ON HER SHOULDER OVER THE WEEKEND. PT REPORTED THAT DURING THE INITIAL SESSION, THAT PRIOR TO THE UNIT SHUTTING OFF, HER SHOULDER FELT LIKE IT "TWISTED" OR "TIGHTENED UP" AND THEN THE UNIT SHUT OFF. SECOND DEGREE BURNS PRESENT AT ELECTRODE SITE ANTERIOR AND POSTERIOR SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL ULTRA III E-STIM OR ELECTRICAL STIMULATING UNIT IPF EXCEL TECH LTD. EX-UL3

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability