BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-PORT

    MDR report key: 2171413 · Received June 11, 2008

    Report

    Report Number
    3006035654-2008-00005
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 9, 2008
    Manufacturer
    PATTON MEDICAL DEVICE
    Product Code
    FOZ
    PMA / PMN Number
    K052389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF AN I-PORT FOLLOWING THREE DAYS OF WEAR, THE APPLICATION SITE BECAME IRRITATED AND DEVELOPED A BUILD-UP OF PUS. THE PATIENT VISITED HER HEALTH CARE PROFESSIONAL'S ("HCP") OFFICE TO DISCUSS THE IRRITATED APPLICATION SITE, AND THE HCP DIAGNOSED THE SITE AS INFECTED AND PRESCRIBED ANTIBIOTICS. A FOLLOW-UP CALL 7 DAYS AFTER THE INITIAL HCP VISIT REVEALED THAT THE INFECTED SITE "IS DOING MUCH BETTER" AND THE PATIENT HAS CONTINUED USING THE I-PORT WITHOUT EXPERIENCING ANOTHER ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-PORT INJECTION PORT FOZ PATTON MEDICAL DEVICE 720130

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization