BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCAM

    MDR report key: 222310 · Received May 7, 1999

    Report

    Report Number
    2126677-1999-00008
    Event Type
    Injury
    Date Received
    May 7, 1999
    Date of Event
    April 7, 1999
    Report Date
    May 7, 1999
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    KPS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT AN ENGINEER BENT OVER TO PICK UP AN OBJECT DROPPED BY A PT AND HIT HIS HEAD ON THE HANDLE ATTACHED TO THE DETECTOR. REPORTEDLY, THREE STITCHES WERE REQUIRED. THE SYSTEM OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCAM NUCLEAR MEDICINE KPS GENERAL ELECTRIC MEDICAL SYSTEMS 46-300130G2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other