BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2860018 · Received October 31, 2012

    Report

    Report Number
    1722139-2012-01102
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP WILL BE SENT WHEN NEW INFO IS RECEIVED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLACK SPOTS INSIDE THE FILTER. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MED DEVICES GROUP 340-4128 CF1134392

    Patients

    Seq Age Sex Outcome Treatment
    1