BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE

    MDR report key: 403666 · Received July 4, 2002

    Report

    Report Number
    8021545-2002-00107
    Event Type
    Injury
    Date Received
    July 4, 2002
    Date of Event
    March 24, 2002
    Report Date
    July 4, 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 04/2002 THE END USER CALLED MEDTRONIC MINIMED, USA AND REPORTED BEING HOSPTIALIZED WITH HIGH BGS. USER CHECKED INTO HOSPITAL ON THE MORNING OF THE EVENT. ON 06/2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED INFUSON SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL A/S 23" UNK

    Patients

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