BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEATHERLITE FLOOD SOURCE

    MDR report key: 1120112 · Received August 15, 2008

    Report

    Report Number
    2029030-2008-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 15, 2008
    Manufacturer
    NORTH AMERICAN SCIENTIFIC
    Product Code
    IXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE MANUFACTURER BELIEVES THE LIKELIHOOD OF SERIOUS INJURY FROM A RECURRENCE OF THIS EVENT IS REMOTE, THE FOLLOWING ACTIONS HAVE BEEN TAKEN. THE VENDOR'S INSPECTION OF THE RETURNED SHIELDING CASE SHOWED THAT THE BOND ON ONE OF THE HINGE ATTACHMENTS WAS INADEQUATE. IT IS BELIEVED THAT WHEN THE FIRST HINGE JOINT FAILED, EXCESSIVE FORCE WAS PLACED ON THE REMAINING HINGE JOINTS RESULTING IN THE FAILURE. THE VENDOR HAS IMPLEMENTED A SECONDARY BONDING STEP DURING FINAL MANUFACTURING PROCESS USING A LOW VISCOSITY WICKING ADHESIVE TO ENSURE THAT ALL HINGE POINTS ARE PROPERLY BONDED.

    Description of Event or Problem · 1

    THE HANDLE FOR A FLOOD SOURCE SHIELDED CASE BECAME DETACHED WHILE THE TECHNICIAN WAS TRANSFERRING THE SOURCE AND CASE TO THE (B) (4) CAMERA. THE CASE FELL ON HER CALF. THE INJURED TECHNICIAN WALKED TO THE ER FOR TREATMENT. SHE WAS GIVEN PAIN MEDICATION; HER LEG WAS WRAPPED IN AN ACE BANDAGE AND ICE, AND WAS TOLD TO STAY OFF HER FEET FOR LONG PERIODS. THE ER REPORT WARNS THAT MUSCLE CONTUSIONS CAUSE BLEEDING IN THE DEEP TISSUES THAT CAN INCREASE THE PRESSURE IN THE EXTREMITY. IT ALSO STATES THAT THERE IS A SMALL CHANCE THAT THE PRESSURE FROM THE BLEEDING AND SWELLING WILL INTERFERE WITH THE CIRCULATION. IF THIS HAPPENS, PERMANENT DAMAGE TO THE MUSCLE CAN OCCUR WITHIN 4-8 HOURS IF UNTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEATHERLITE FLOOD SOURCE NORTH AMERICAN SCIENTIFIC IXD NORTH AMERICAN SCIENTIFIC MED3709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention