BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2277311 · Received September 28, 2011

    Report

    Report Number
    3003442380-2011-00018
    Event Type
    Death
    Date Received
    September 28, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 28, 2011
    Manufacturer
    UNOMEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO USED OR UNUSED DEVICES WERE RETURNED TO UNOMEDICAL A/S. DUE TO THE FACT THAT NO LOT NUMBER WAS AVAILABLE THE RETAINED SAMPLES FROM THE RESERVE LOT COULD NOT BE TESTED. IF WE RECEIVE THE USED DEVICE, WE WILL TEST AND EVALUATE AND, IF THE RESULT REQUIRES A F/U REPORT, WE WILL RE-OPEN THE CASE AND A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(6) CALLED AND STATED THAT PT HAD PASSED AWAY ON (B)(6) 2011 AT (B)(6) HOSPITAL. CAUSE OF DEATH IS UNK. REPORTER STATED THAT PT WAS NOT WEARING THE PUMP AT THE TIME OF DEATH AND UNSURE OF DATE PT LAST WORE THE PUMP BEFORE PASSING. REPORTER AGREED TO SEND THE SET AND HAD NO ADD'L INFO TO PROVIDE IN REFERENCE TO PT PASSING. PT HCP INFO: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM INFUSION SET FPA UNOMEDICAL DEVICE S.A. DE C.V. MMT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death