BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 666836 · Received January 11, 2006

    Report

    Report Number
    1125759-2005-00003
    Event Type
    Other
    Date Received
    January 11, 2006
    Date of Event
    October 24, 2005
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    ---
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTS ON BACTERIAL CONTAMINATION FROM OTHER INSTITUTIONS IN THIS SYSTEM LED TO SUBMISSION OF MICOBIOLOGIC STUDIES OF EQUIPMENT. THESE STUDIES GREW RALSTONIA PICKETTII FROM THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * --- VAPOTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other