BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL FIXATOR DEVICE

    MDR report key: 4284204 · Received September 15, 2014

    Report

    Report Number
    4284204
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    UNK
    Product Code
    NDK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT TURNED TO THE LEFT SIDE DURING CHLORHEXIDINE BATH. EXTERNAL FIXATOR DEVICE CAUSED A GASH IN THE MEDIAL ASPECT OF LEFT LEG. CCM AWARE AND HAS VIEWED THE SKIN ALTERATION. CCM STATES THEY WILL NOTIFY ORTHO. CHARGE NURSE NOTIFIED. AWAITING FURTHER ORDERS FROM CCM OR ORTHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569047 EXTERNAL FIXATOR DEVICE SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS) NDK UNK UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R