BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOSCAN LX/C

    MDR report key: 69579 · Received February 11, 1997

    Report

    Report Number
    1217116-1997-00005
    Event Type
    Injury
    Date Received
    February 11, 1997
    Date of Event
    January 18, 1995
    Report Date
    January 19, 1995
    Manufacturer
    HITACHI MEDICAL SYSTEMS
    Product Code
    JAK
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER PERFORMED A BIOPSY ON THE WRONG SIDE OF THE PT'S HEAD DUE TO CONFUSION OF LEFT/RIGHT ORIENTATION WHEN VIEWING THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOMOSCAN LX/C CT SCANNER JAK HITACHI MEDICAL SYSTEMS 9807-011-20009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention