BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MEDIUM ELONGATED ADULT MASK

    MDR report key: 2093373 · Received April 19, 2011

    Report

    Report Number
    3004365956-2011-00151
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 28, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE OXYGEN TUBE TO THE MASK WAS FOUND OCCLUDED JUST BEFORE USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON MEDIUM ELONGATED ADULT MASK ELONGATED MASK BYG TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1