BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1515285 · Received October 6, 2009

    Report

    Report Number
    1515285
    Event Type
    Malfunction
    Date Received
    October 6, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 6, 2009
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN OUT-PATIENT REHAB COMPLETING AN EXERCISE ON A CABLE COLUMN. THE CABLE SUPPORT RING THAT COVERED THE LINK BETWEEN THE CABLE AND THE PATIENT HANDLE BROKE AND EXPOSED A METAL EDGE. THE PATIENT RECEIVED A SKIN TEAR FROM THE EXPOSED BARB. THE AREA WAS CLEANED WITH ALCOHOL. BANDAID AND PRESSURE APPLIED.

    Description of Event or Problem · 1

    THE PATIENT WAS IN OUT-PATIENT REHAB COMPLETING AN EXERCISE ON A CABLE COLUMN. THE CABLE SUPPORT RING THAT COVERED THE LINK BETWEEN THE CABLE AND THE PATIENT HANDLE BROKE AND EXPOSED A METAL EDGE. THE PATIENT RECEIVED A SKIN TEAR FROM THE EXPOSED BARB. THE AREA WAS CLEANED WITH ALCOHOL. BANDAID AND PRESSURE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK BIODEX MEDICAL SYSTEMS, INC 940-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO OTHER THERAPIES| NO OTHER THERAPIES