BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATTANOOGA GROUP

    MDR report key: 3901891 · Received June 23, 2014

    Report

    Report Number
    MW5036888
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 20, 2014
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SKILLED NURSING FACILITY PATIENT WITH HISTORY OF TOTAL KNEE REPLACEMENT TO RIGHT. RECEIVING SKILLED PHYSICAL THERAPY INCLUDING IFC (E-STIM) TREATMENT WITH COLD PACK TO RIGHT KNEE SKIN CONDITION DOCUMENTED AS INTACT PRIOR TO INITIAL TREATMENT AND INTACT FOLLOWING TREATMENT. PATIENT RESPONSE TO TREATMENT DOCUMENTED AS NO C/O ABOUT TINGLING OR BURNING. UNDERWENT THREE MORE TREATMENTS WITHOUT ANY COMPLICATIONS. ON (B)(6) 2014, PATIENT REC'D 5TH E-STIM TREATMENT TO RIGHT KNEE. SKIN INTACT PRIOR TO TREATMENT, FOLLOWING REMOVAL OF ELECTRODES A YELLOW DISCOLORATION NOTED TO LATERAL SIDE OF RIGHT KNEE. INITIAL INTERVENTIONS INCLUDED MEDICATION TO AFFECTED AREAS, BUT WOUNDS LATER REQUIRED SURGICAL DEBRIDEMENT TWO TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367072 CHATTANOOGA GROUP E-STIM GZJ CHATTANOOGA GROUP, INC. 2865

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention