BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1982779 · Received January 31, 2011

    Report

    Report Number
    3003442380-2011-00003
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    October 19, 2010
    Report Date
    January 31, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: USED DEVICE: ONE USED DEVICE WAS RETURNED FOR EVALUATION. A VISUALLY INSPECTION, A FLOW AND LEAK TEST WAS CONDUCTED ON THE USED DEVICE AND THE DEVICE WAS FOUND TO BE WITHIN PRODUCT SPECIFICATION. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR EVALUATION. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE NOT TESTED, DUE TO LOT NUMBER UNK. (B)(6).

    Description of Event or Problem · 1

    THE COMPLAINT: (B)(4) RETURNED TUBING. DEACTIVATING ACCOUNT AND REMOVING PT FROM MAILING LIST. (B)(4) FOR RETURNING TUBING. ONE USED DEVICE WAS RETURNED. ACCORDING TO COMPLAINT DESCRIPTION, THE DEATH CAUSE COULD NOT BE LINKED TO THE USE OF THE INFUSION SET. UOMEDICAL A/S TRIED TO GET THE EVENT CONFIRMED WITH THE DISTRIBUTOR (B)(4), BUT THE DISTRIBUTOR WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION. IN CASE OF FURTHER INFORMATION REQUESTED, PLEASE CONTACT THE DISTRIBUTOR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM NONE FPA UNOMEDICAL A/S MMT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death