BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE

    MDR report key: 391319 · Received April 24, 2002

    Report

    Report Number
    8021545-2002-00052
    Event Type
    Malfunction
    Date Received
    April 24, 2002
    Date of Event
    September 12, 2001
    Report Date
    April 23, 2002
    Manufacturer
    MAERSK MEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 02/2001 THE END-USER CALLED METRONIC MINIMED, USA AND STATED THAT A LEAK WAS FOUND AT THE LUER LOCK. HIGH BGS. ON 03/2002 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 23" 525358

    Patients

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