BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATTANOOGA

    MDR report key: 7826983 · Received August 29, 2018

    Report

    Report Number
    9616086-2018-00021
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    July 16, 2018
    Report Date
    August 29, 2018
    Manufacturer
    DJO, LLC
    Product Code
    IOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "GREY FLEECE PATIENT KIT WAS DETACHED OFF THE MAIN UNIT ALONG WITH PATIENT'S RIGHT LOWER CALF AND MACHINERY FRAMES HAS PINCHED THE PATIENT'S LEG, AND BROKE 4TH AND 5TH METATARSAL BONES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667288 CHATTANOOGA OPTIFLEX III PKG, INT'L STD IOE DJO, LLC 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other