BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATTANOOGA TENS UNIT

    MDR report key: 2400978 · Received January 4, 2012

    Report

    Report Number
    9616086-2012-00002
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 1, 2010
    Report Date
    January 4, 2012
    Manufacturer
    DJO, LLC
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LETTER SENT FROM A LAWYER'S OFFICE REGARDING A CUSTOMER INJURY COMPLAINT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PT WENT TO THE ER AFTER SUFFERING SECOND DEGREE BURNS FROM ONE OF CHATTANOOGA'S TENS UNITS. THE COMPANY HAS BEEN UNABLE TO INSPECT THE DEVICE. BECAUSE THE MATTER IS IN LITIGATION, IT HAS BEEN TURNED OVER TO OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHATTANOOGA TENS UNIT ELECTROTHERAPY - CLINIC GZJ DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other