BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 4102635 · Received September 9, 2014

    Report

    Report Number
    2183502-2014-00656
    Event Type
    Injury
    Date Received
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN IN-HOME DEVICE USER STATING THAT WHEN THE LISTED INFUSION SET WAS REMOVED FROM THE USER'S LEFT LEG, THE INSERTION SITE WAS WARM, RED, AND SWOLLEN REPORTEDLY DUE TO INFECTION. THE USER WENT TO HIS PHYSICIAN FOR TREATMENT. THE DEVICE USER WAS PLACED ON AUGMENTIN FOR A 10 DAY CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553344 CLEO 90 INFUSION SET FPA - SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention