BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE BRAIN IMC PROBE KIT

    MDR report key: 1216066 · Received October 29, 2008

    Report

    Report Number
    9617494-2008-00006
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Report Date
    October 29, 2008
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE OXYGEN PROBE CC1.SB (LOT 020407, (B) (4)) AND AN IM1 INTRODUCER (WITHOUT IM1 BOLT SCREW). THE PROBE ARRIVED WITHOUT THE PROTECTIVE SLEEVE. VISUAL INSPECTION OF THE CATHETER: THE CATHETER TUBE WAS FOUND CUT AT APPROX. 85MM FROM THE LUER CONNECTOR. THE SEPARATED PROBE TIP (APPROX. 65MM) WAS MISSING. DUE TO THE EXTENSIVE DAMAGE TO THE PROBE, A PLAUSIBILITY CHECK WAS NOT POSSIBLE. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHEN HE STARTED TO PUT THE DEVICE IN, THE CATHETER WAS BROKEN AND IT WAS TOO SHORT FOR THE BOLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE BRAIN IMC PROBE KIT LICOX DISPOSABLE GWM 1030607

    Patients

    Seq Age Sex Outcome Treatment
    1