BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-PORT

    MDR report key: 3004027 · Received February 6, 2008

    Report

    Report Number
    3006035654-2008-00002
    Event Type
    Injury
    Date Received
    February 6, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 6, 2008
    Manufacturer
    PATTON MEDICAL DEVICES
    Product Code
    FOZ
    PMA / PMN Number
    K052389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE TELEPHONE CONVERSATION, THE CALLER INFORMED PMD THAT THE DEVICE WORN BY PT ALLEGEDLY CONTRIBUTING TO ADMITTANCE TO THE HOSPITAL WAS AVAILABLE TO RETURN TO PMD FOR ANALYSIS. A DEVICE RETURN PACKAGE WAS DELIVER TO THE CALLER AS DISCUSSED DURING THE TELEPHONE CONVERSATION, BUT THE PMD MFG FACILITY HAS NOT RECEIVED THE RETURNED DEVICE AND SHIPPING RECORDS INDICATE, AS OF (B)(4) 2008, THAT THE DELIVERED DEVICE RETURN PACKAGE WAS NOT SENT BY THE CALLER.

    Description of Event or Problem · 1

    OUTBOUND CALL PLACED TO PT'S MOTHER BROUGHT FORTH INFO THAT THE PT WAS BRIEFLY HOSPITALIZED DUE TO ELEVATED BLOOD GLUCOSE LEVELS WHILE WEARING AN I-PORT. CALLER CLAIMS THAT VISUAL INSPECTION OF THE DEVICE FOLLOWING REMOVAL WHILE IN ROUTE TO THE HOSPITAL REVEALED A L SHAPE BEND IN THE CANNULA. CALLER STATED THAT THE PT WAS IN THE HOSPITAL "NOT LONG AT ALL" AND THE ACTIONS TAKEN BY THE HOSPITAL CONSISTED OF AN INJECTION OF INSULIN WITH A SYRINGE TO BRING DOWN THE PT'S BLOOD GLUCOSE LEVELS. CALLER CLAIMED NO PERMANENT EFFECTS FROM THE ADVERSE EVENT AND PT HAS WORN ANOTHER DEVICE SINCE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-PORT INJECTION PORT FOZ PATTON MEDICAL DEVICES 010110

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization