BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1445023 · Received August 6, 2009

    Report

    Report Number
    9610617-2009-00024
    Event Type
    Other
    Date Received
    August 6, 2009
    Date of Event
    June 10, 2009
    Report Date
    August 5, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INSTRUCTIONS FOR USE AND LABELING ON THE SIDE OF THE PORTABLE LIGHT SOURCE CAUTION USER TO USE THIS PORTABLE LIGHT SOURCE FOR NO LONGER THAN 10 MIN AND THEN POWER OFF FOR 5 MIN TO COOL. OUR INSTRUCTIONS FOR USE ALSO CAUTION THE USER NOT TO HAVE DEVICE IN PROXIMITY OF PATIENT. SO PORTABLE LIGHT SOURCE SHOULD NOT HAVE BEEN RUNNING CONTINUOUSLY FOR THE 2.5 HOUR PROCEDURE AND SHOULD NOT HAVE BEEN ATTACHED TO PATIENT. HOSPITAL WAS SO ADVISED.

    Description of Event or Problem · 1

    ALLEGEDLY, HOSPITAL STAFF ATTACHED PORTABLE LIGHT SOURCE TO PATIENT'S THIGH DURING 2.5 HOUR PROCEDURE AND PATIENT RECEIVED A 1.5" X 3" BURN IN THAT LOCATION. THEY APPLIED OINTMENT TO THE BURN SITE. PATIENT IN STABLE CONDITION POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ PORTABLE LIGHT SOURCE FCW KARL STORZ GMBH & CO. KG 11301D4 BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other