BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC TENDER

    MDR report key: 541336 · Received August 25, 2004

    Report

    Report Number
    8021545-2004-00001
    Event Type
    Death
    Date Received
    August 25, 2004
    Report Date
    August 25, 2004
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN JULY 2004 UNOMEDICAL WAS INFORMED BY DISETRONIC MEDICAL SYSTEMS THAT A DIABETIC UNDER CONTINOUS INSULIN INFUSION THERAPY HAS DIED, AND THAT THE REASON FOR THE PTS DEATH IS STILL UNK. UNOMEDICAL A/S HAS RECEIVED THAT COMPLAINT, 4 UNUSED INFUSION SETS AND 4 UNUSED CANNULA PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC TENDER SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S PT 17/60 (5+5) 518864

    Patients

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