BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOF-SET

    MDR report key: 11631 · Received February 17, 1994

    Report

    Report Number
    MW1000819
    Event Type
    Other
    Date Received
    February 17, 1994
    Date of Event
    February 2, 1994
    Report Date
    February 2, 1994
    Manufacturer
    MINI-MED TECHNOLOGIES
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CATHETER ON INFUSION SET IS DESCRIBED AS BEING "TOO FAT" FOR COMFORTABLE INSERTION. MFR IS AWARE OF PROBLEM BUT HAS NOT RECALLED THIS LOT #. NEWER STYLE OF INFUSION SET IS BEING OFFERED UNDER SAME MODEL #. RPTR FEELS THIS SHOULD NOT BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-SET FOZ MINI-MED TECHNOLOGIES MMT-111 620680

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other GRASEBY SYRINGEDRIVER