BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPECTRA TISSUE SPECTROMETER

    MDR report key: 527440 · Received May 24, 2004

    Report

    Report Number
    527440
    Event Type
    Injury
    Date Received
    May 24, 2004
    Date of Event
    May 19, 2004
    Report Date
    May 20, 2004
    Manufacturer
    HUTCHINSON TECHNOLOGY, INC./BIOMEASUREMENT DIV.
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH INSPECTRA TISSUE SPECTROMETER. PT HAD INSPECTRA SHIELD CHANGED PRIOR TO 24 HOUR PROTOCOL REQUIREMENT. WHEN REMOVED, NOTED TO HAVE 4X1.5X0.1 CM LINEAR SKIN LOSS. TREATMENT WITH DUODERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPECTRA TISSUE SPECTROMETER INSPECTRA 12-25 MM SHIELD GCJ HUTCHINSON TECHNOLOGY, INC./BIOMEASUREMENT DIV. * 1271

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention