BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD EXTENSION SETS

    MDR report key: 2233881 · Received August 26, 2011

    Report

    Report Number
    2183502-2011-00599
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 17, 2011
    Report Date
    August 25, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K974013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND REVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE PT BECAME ILL DURING THE INFUSION OF MEDICATION AND WAS ADMITTED TO THE HOSPITAL. AT THE HOSPITAL, THE PT'S PUMP WAS EXCHANGED BUT THIS DID NOT IMPROVE THE PT'S SYMPTOMS. THE PT INFUSION SET WAS EXCHANGED WHICH ELEVATED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD EXTENSION SETS FPA - SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7106 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization