BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 246573 · Received October 25, 1999

    Report

    Report Number
    1527736-1999-05486
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    July 19, 1999
    Report Date
    July 19, 1999
    Manufacturer
    INDIGO MEDICAL INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE FIBERS WITH DIFFUSER FAULT (FIBER BREAKAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER INDIGO-FIBER GEX INDIGO MEDICAL INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other