BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 384014 · Received March 18, 2002

    Report

    Report Number
    8021545-2002-00039
    Event Type
    Injury
    Date Received
    March 18, 2002
    Date of Event
    January 30, 2002
    Report Date
    March 15, 2002
    Manufacturer
    MAERSK MEDICAL 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

    IN 2002 THE END-USER CALLED MEDTRONIC MINIMED, USA DUE TO HOSPITALIZATION FOR HIGH BLOOD GLUCOSE. THE END-USER STATES NO LEAKS. ON 03/2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 14 UNUSED INFUSION SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL A/S 23" - 6MM 526990

    Patients

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