BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLEX

    MDR report key: 300322 · Received October 13, 2000

    Report

    Report Number
    1022819-2000-00002
    Event Type
    Injury
    Date Received
    October 13, 2000
    Date of Event
    October 9, 2000
    Report Date
    October 12, 2000
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    BXB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY ON LEFT KNEE. PT CAME OUT OF SURGERY AT 12:30 PM, PLACED ON DEVICE. THE PT WAS GIVEN HIGH DOSES OF MORPHINE AND WAS NOT AWAKE. THE DEVICE WAS COVERED WITH A SHEET/BLANKET. AT 6:30PM IT WAS DISCOVERED THE PT'S RIGHT FOOT HAD BEEN WEDGED UNDER THE CARRIAGE AND BEEN CUT. THE CUT WAS BETWEEN THE FIRST AND SECOND TOES AND REQUIRED NINE STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX CONTINUOUS PASSIVE MOTION BXB CHATTANOOGA GROUP, INC. OPTIFLEX II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention