BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATTANOOGA

    MDR report key: 4987781 · Received August 10, 2015

    Report

    Report Number
    9616086-2015-00022
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 6, 2015
    Manufacturer
    DJO, LLC
    Product Code
    GZI
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "UNIT CAUSED 2ND DEGREE BURN ON PATIENT". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521722 CHATTANOOGA INTELECT LEGEND GZI DJO, LLC 2760

    Patients

    Seq Age Sex Outcome Treatment
    1 Other