BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/TEE & TUBING SMALL VOLUME

    MDR report key: 2021321 · Received February 7, 2011

    Report

    Report Number
    3004365956-2011-00049
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 17, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED IN TIME FOR THIS REPORT. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PRODUCT LEAKING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER W/TEE & TUBING SMALL VOLUME NEBULIZER CAF TELEFLEX MEDICAL NA 02C1001037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA