BEUDAMED
    FDA Adverse Event Summary report: N

    COMPAT

    MDR report key: 2310490 · Received October 17, 2011

    Report

    Report Number
    2110851-2011-00002
    Date Received
    October 17, 2011
    Date of Event
    September 6, 2011
    Report Date
    October 12, 2011
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    LZH
    PMA / PMN Number
    K940556
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHARGE NURSE WAS CALLED BY ATTENDING NURSE THE MORNING OF THE EVENT TO EVALUATE THE APPEARANCE OF TWO ABDOMINAL WOUNDS ON THE PATIENT. THE WOUNDS WERE CONTAINED TO THE SUPERFICIAL SUBCUTANEOUS TISSUE AND WERE THOUGHT TO BE CAUSED BY THE PATIENT LYING ON THE PLASTIC DISTAL END OF THE FEEDING ADMINISTRATION SET WHEN BEING TURNED. BOTH WOUNDS WERE APPROXIMATELY 4 INCHES FROM THE NAVEL. THE WOUNDS WERE WASHED WITH NORMAL SALINE AND LEFT TO OPEN AIR TO HEAL. AT THE TIME OF THIS REPORT, BOTH WOUNDS HAVE COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT COMPAT ADMINISTRATION SET WITH Y PORT LZH NESTLE HEALTHCARE NUTRITION, INC. 199547

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention