BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE

    MDR report key: 434438 · Received December 17, 2002

    Report

    Report Number
    8021545-2002-00248
    Event Type
    Malfunction
    Date Received
    December 17, 2002
    Date of Event
    October 31, 2002
    Report Date
    December 13, 2002
    Manufacturer
    MAERSK MEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN 2002 THE END-USER'S PARENT CALLED MEDTRONIC MINIMED, USA AND STATED THAT THE END-USER WOKE UP AND THERE WAS A LEAK AT THE CONNECTION FROM THE RESERVOIR TO THE INFUSION SET. ON 12/09/2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL A/S 43" UNK

    Patients

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