BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 418214 · Received September 16, 2002

    Report

    Report Number
    8021545-2002-00142
    Event Type
    Malfunction
    Date Received
    September 16, 2002
    Date of Event
    July 29, 2002
    Report Date
    September 12, 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

    THE BASE-PIECE DETACHES FROM THE TAPE. ON SEPTEMBER 09, 2002 MAERSK MEDICAL RECEIVED THE COMPLAINT AND 1 USED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL A/S 43"-9MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 1. INSULIN, 2. INSULIN INFUSION PUMP.