BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIMED

    MDR report key: 468800 · Received June 24, 2003

    Report

    Report Number
    MW1028822
    Event Type
    Other
    Date Received
    June 24, 2003
    Date of Event
    June 20, 2003
    Report Date
    June 24, 2003
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSO
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING CATHETER FROM PT, IT WAS NOTED THAT THE PLASTIC COVERING CRACKED. THE CATHETER WAS SUCCESSFULLY REMOVED AND NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIMED NEUROPLASTY CATHETER BSO EPIMED INTERNATIONAL * 11241012

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other