BEUDAMED
    FDA Adverse Event Other Summary report: N

    F-10

    MDR report key: 397808 · Received May 31, 2002

    Report

    Report Number
    1221261-2002-00029
    Event Type
    Other
    Date Received
    May 31, 2002
    Date of Event
    January 1, 1998
    Report Date
    May 31, 2002
    Manufacturer
    LEVEL 1, INC.
    Product Code
    BRZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP ALLEGES THAT THE F-10 WOULDN'T PRIME BUT WOULD FILL UP WITH AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F-10 FILTER WITH GAS VENT REPLACEMENT BRZ LEVEL 1, INC. F-10 199805B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other