BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILLIPS SIEMENS

    MDR report key: 296360 · Received September 13, 2000

    Report

    Report Number
    296360
    Event Type
    Other
    Date Received
    September 13, 2000
    Date of Event
    August 14, 2000
    Report Date
    September 8, 2000
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS
    Product Code
    IWQ
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAD SHIELD (GLASS) SEPARATED FROM ARM AND FELL. GRAZED PT - NO SKIN TEAR OR BRUISING. POSSIBLE FRACTURE TO PHYSICIAN'S ARM. MINIMUM WELDING NOTED AT SAME SITE ON OTHER ARM. OCCURRED IN CATH LAB. THE SHIELD SEPARATED FROM THE DEVICE AND FELL ON A PHYSICIAN'S ARM, CAUSING A HAIRLINE FRACTURE. IT GRAZED THE PT, BUT CAUSED NO INJURY TO THE PT. CATH LAB PERSONNEL NOTIFIED THE CO IMMEDIATELY, AND HOSP MAINTENANCE DEPT MADE THE NECESSARY REPAIR. THE INCIDENT OCCURRED 8/14/00, HOWEVER RISK MGMT WAS NOT MADE AWARE UNTIL 9/8/00, AT WHICH TIME A REPORT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS SIEMENS LEAD GLASS SHILED ON ARM IWQ PHILLIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other