BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 1191466 · Received September 25, 2008

    Report

    Report Number
    2031921-2008-00033
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CURLIN MEDICAL, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND RECEIVED ON 09/17/08. THE DEVICE IS AWAITING INVESTIGATION. A FOLLOW UP WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    CURLIN MEDICAL WAS INFORMED OF A REPORTABLE EVENT IN 2008 BY A CUSTOMER. NO PT INJURY WAS REPORTED. THE DISPOSABLE SET WAS LEAKING AT THE FILTER WHILE ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN CURLIN ADMINISTRATION SET FPA CURLIN MEDICAL, INC 340-4119 D 711308

    Patients

    Seq Age Sex Outcome Treatment
    1