BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET

    MDR report key: 2425864 · Received January 13, 2012

    Report

    Report Number
    3003442380-2012-00001
    Event Type
    Death
    Date Received
    January 13, 2012
    Date of Event
    October 17, 2011
    Report Date
    January 13, 2012
    Manufacturer
    UNOMEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K992300
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO TESTS WERE PERFORMED DUE TO NO DEVICES RETURNED AND LOT NUMBER BEING UNKNOWN. FURTHER INFO WAS BEEN REQUESTED AT THE DISTRIBUTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2011 PATIENT HAS SUFFERED HYPERGLYCEMIA SEVERAL DAYS AND SHE WAS FOUND DECEASED AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET INFUSION SET FPA UNOMEDICAL DEVICE S.A. DE C.V. MMT-392 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death