BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYGEN MASK

    MDR report key: 865774 · Received June 15, 2007

    Report

    Report Number
    3004365956-2007-00025
    Event Type
    Other
    Date Received
    June 15, 2007
    Report Date
    May 21, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT MADE AVAILABLE FOR EVAL. THE LOT CODE # OF THIS DEVICE WAS ALSO NOT MADE AVAILABLE AND THEREFORE, A REVIEW OF THE DHR WAS UNABLE TO BE CONDUCTED. METHOD: NO SAMPLES OR LOT CODES PROVIDED.

    Description of Event or Problem · 1

    THE NOSE PIECE OR TOP PART OF THE OXYGEN MASK POPS OFF, CAUSING CORNEAL ABRASIONS TO PTS. THE PROD AND LOT CODE WERE NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN MASK OXYGEN MASK BYG TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention