BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE

    MDR report key: 395887 · Received May 17, 2002

    Report

    Report Number
    8021545-2002-00073
    Event Type
    Malfunction
    Date Received
    May 17, 2002
    Date of Event
    February 22, 2002
    Report Date
    May 16, 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 2002, THE END-USER CALLED MEDTRONIC MINIMED, USA AND STATED THAT THE TUBING SEPARATED FROM THE CONNECTION. ON APRIL 17, 2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED TUBING. THE NEAR-INCIDENT TOOK PLACE IN USA.

    Description of Event or Problem · 1

    IN 2/22/02, THE END-USER CALLED MEDTRONIC MINIMED, USA AND STATED THAT THE TUBING SEPARATED FROM THE CONNECTION. ON 17, 2002 MAERSK MEDICAL A/S REC'D THE COMPLAINT AND 1 USED TUBING. THE NEAR-INCIDENT PLACE IN USA.

    Devices

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

    Patients

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