BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPECTRA TISSUE SPECTROMETER SYSTEM MODEL 325

    MDR report key: 530340 · Received June 11, 2004

    Report

    Report Number
    2184064-2004-00001
    Event Type
    Injury
    Date Received
    June 11, 2004
    Date of Event
    May 19, 2004
    Report Date
    May 21, 2004
    Manufacturer
    HUTCHINSON TECHNOLOGY, INC., BIOMEASUREMENT DIVISION
    Product Code
    MUD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPECTRA TISSUE SPECTROMETER SYSTEM MODEL 325 TISSUE OXIMETER MUD HUTCHINSON TECHNOLOGY, INC., BIOMEASUREMENT DIVISION 325 SHIELD LOT 12171

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other