BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-PORT

    MDR report key: 2190172 · Received October 24, 2007

    Report

    Report Number
    3006035654-2007-00006
    Event Type
    Injury
    Date Received
    October 24, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 22, 2007
    Manufacturer
    PATTON MEDICAL DEVICE
    Product Code
    FOZ
    PMA / PMN Number
    K052389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT STATED THAT NEITHER SHE NOR THE PRESCRIBING PHYSICIAN, WHO INSTRUCTED THE PATIENT ON PROPER APPLICATION OF THE DEVICE AND APPLIED THE DEVICE GIVING RISE TO THIS EVENT, SWABBED THE INSERTION SITE WITH ALCOHOL OR SIMILAR DISINFECTANT PRIOR TO DEVICE APPLICATION. THE USER GUIDE CLEARLY STATES TO "SWAB THE SKIN WITH ALCOHOL OR SIMILAR DISINFECTANT WHERE YOU INTEND TO APPLY THE I-PORT."

    Description of Event or Problem · 1

    PATIENT NOTIFIED PMD THAT THE AREA AROUND THE INSERTION SITE BECAME IRRITATED AND POSSIBLY INFECTED FOLLOWING THREE DAYS OF DEVICE WEAR. PATIENT TELEPHONED THE PRESCRIBING PHYSICIAN TO NOTIFY HER OF THE DISCOMFORT. BASED ON THE INFORMATION PROVIDED BY THE PATIENT VIA TELEPHONE, THE PRESCRIBING PHYSICIAN DIAGNOSED THE CONDITION AS A POSSIBLE STAPH INFECTION AND PRESCRIBED PENICILLIN. FURTHER MEDICAL INTERVENTION WAS NOT NECESSARY AND THE PATIENT HAS NOT SUFFERED ANY PERMANENT EFFECTS. SUSPECT DEVICE WAS NOT AVAILABLE FOR RETURN TO CONDUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-PORT INJECTION PORT FOZ PATTON MEDICAL DEVICE 010210

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention