BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP CE SAPH3 SS LIGHT PANEL

    MDR report key: 383801 · Received March 19, 2002

    Report

    Report Number
    1221601-2002-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2002
    Date of Event
    February 21, 2002
    Report Date
    March 19, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GENZYME
    Product Code
    FBM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT WHILE USING THE SAPHLITE SYSTEM, THE LIGHT PANEL BEGAN TO SMOKE WHILE IN THE LEG INCISION. THE UNIT WAS IMMEDIATELY REMOVED FROM THE PATIENT AND UPON EXAMINATION, THE LIGHT PANEL WAS REPORTED TO HAVE A CRACK JUST BELOW THE ELBOW BEND AND APPEARED TO BE CHARRED. THE DAMAGED LIGHT PANEL WAS REMOVED AND A NEW PANEL WAS PLACED INTO THE SAPHLITE SYSTEM. THE CASE WAS COMPLETED WITH THE NEW PANEL WITHOUT ANY OCCURANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP CE SAPH3 SS LIGHT PANEL SAPHLITE SYSTEM LIGHT PANEL FBM GENZYME BIOSURGERY A DIVISION OF GENZYME 89-2718 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other