BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-LEG/C-LEG TUBE ADAPTER

    MDR report key: 1060403 · Received June 10, 2008

    Report

    Report Number
    2182293-2008-00001
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    ISW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ON THE WAY TO THE HOSP WHEN THE STANCE PHASE DAMPING OF THE KNEE JOINT FAILED. THE PT FELL AND INCURRED A SPLINTERING OF THE BONE WHICH HAD TO BE OPERATED ON IN THE HOSP. POSSIBLE REASON FOR THE FAILURE WAS A DEFECT OF THE C-LEG TUBE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-LEG/C-LEG TUBE ADAPTER ISW/ISY ISW OTTO BOCK HEALTHCARE PRODUCTS GMBH 3C881/2R91=160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization