BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 924608 · Received August 23, 2004

    Report

    Report Number
    1219702-2004-00001
    Event Type
    Malfunction
    Date Received
    August 23, 2004
    Date of Event
    August 9, 2004
    Report Date
    August 10, 2004
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-SPIKE DISPOSABLE SET DISPOSABLE SET FPA BELMONT INSTRUMENT CORP. NA 2004-05-04 & UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other