BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLEX

    MDR report key: 1901236 · Received November 4, 2010

    Report

    Report Number
    1901236
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    CHATTANOOGA GROUP INC.
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSFERRED FROM ORTHO FLOOR AFTER TOTAL KNEE SURGERY TO ICU DUE TO RESPIRATORY COMPLICATIONS. STAFF IN ICU CONTINUED USING THE CPM (CONTINUOUS PASSIVE MOTION) SEVERAL TIMES MOST OF THE NIGHT WHICH PRECLUDED BEING ABLE TO REPOSITION PATIENT OFF OF COCCYX, RESULTING IN STAGE IV DECUBITUS ULCER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SEE ABOVE--IT FORCED US TO KEEP HER ON HER BACK WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX CPM--CONTINUOUS PASSIVE MOTION BXB CHATTANOOGA GROUP INC. USD437014S *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R CARDIAC DRUGS