BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC TENDER

    MDR report key: 578652 · Received March 4, 2005

    Report

    Report Number
    8021545-2005-00002
    Event Type
    Death
    Date Received
    March 4, 2005
    Date of Event
    March 1, 2004
    Report Date
    March 4, 2005
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN FEBRUARY 2005. UNOMEDICAL A/S WAS INFORMED THAT A PT WAS FOUND DEAD. THE POST MORTEM EXAMINATION COULD NOT DETERMINE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC TENDER SUBCUTANEOUS INFUSION SET FOZ UNOMEDICAL A/S PT 13/60 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death INSULIN: INSULIN INFUSION PUMP.