BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC TENDER

    MDR report key: 460602 · Received May 15, 2003

    Report

    Report Number
    8021545-2003-00042
    Event Type
    Death
    Date Received
    May 15, 2003
    Date of Event
    December 6, 2002
    Report Date
    May 15, 2003
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON APRIL 01, 2003 DISETRONIC MEDICAL SYSTEM WAS INFORMED THAT A PT DIED FOR UNK REASON IN A CAR ACCIDENT. ON MAY 02, 2003 UNOMEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED INFUSION SET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death INSULIN, INSULIN INFUSION PUMP.