BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEA PORT

    MDR report key: 15295 · Received January 14, 1994

    Report

    Report Number
    15295
    Event Type
    Malfunction
    Date Received
    January 14, 1994
    Date of Event
    October 15, 1993
    Report Date
    October 20, 1993
    Manufacturer
    HARBOR MEDICAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SURGERY 10/15/93 "REMOVAL OF MALFUNCTION" SEA PORT AND PLACEMENT OF ANOTHER PORT. DOCUMENTATION STATES PATIENT IS TO HAVE POOR UENOUS ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA PORT Implant PORT FOR CHEMOTHECAPY HARBOR MEDICAL 552002

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other