BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4336828 · Received December 12, 2014

    Report

    Report Number
    3003442380-2014-00098
    Event Type
    Death
    Date Received
    December 12, 2014
    Report Date
    December 4, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE STARTED AN INVESTIGATION TO SEE IF WE CAN GET ANY USED DEVICE BACK FOR TESTING AND A COPY OF THE DEATH CERTIFICATE HAS BEEN REQUESTED. PENDING FURTHER INVESTIGATION. A FOLLOW UP WILL BE SUBMITTED NO LATER THAN 01/06/2015.

    Description of Event or Problem · 1

    ON (B)(6) 2014 MY SON HAD A PUMP THAT HE WAS WEARING AT THE TIME OF HIS DEATH. MEDTRONIC SHIPPING/RECEIVING SUPERVISOR (B)(6) INDICATED THE PUMP WAS RETURNED TO MEDTRONIC WITH THE RESERVOIR AND INFUSION SET INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808175 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-397

    Patients

    Seq Age Sex Outcome Treatment
    1 Death