BEUDAMED
    FDA Adverse Event Summary report: N

    NASAL CANNULA

    MDR report key: 10666 · Received November 30, 1993

    Report

    Report Number
    MW4000052
    Date Received
    November 30, 1993
    Manufacturer
    DEVILBISS HEALTH CARE, INC.
    Product Code
    CAT
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT SHE HAS BEEN ON OXYGEN THERAPY FOR ABOUT 5 YRS BECAUSE OF A "PULMONARY DYSFUNCTION," I.E. "ALLERGIC TO POLLUTANTS IN THE AIR." SHE PURCHASES "NASAL CANNULAS" AT A PHARMACY. THESE CANNULAS ARE MFG OR DISTRIBUTED BY SEVERAL FIRMS LOCATED THROUGHOUT THE U.S. SHE CLAIMS THAT ABOUT 95% OF THE CANNULAS SHE HAS PURCHASED DURING THE PAST 4 OR 5 YRS HAVE HAD A "STRONG PETROLEUM ODOR." SHE SAID THAT SHE HAS WRITTEN TO FIVE OF THE MFRS OF THE CANNULAS AND ONLY TWO RESPONDED. THESE WERE: THIS CO AND ANOTHER CO. ACCORDING TO THE COMPLAINANT, THE SECOND CO SUGGESTED AIRING THE CANNULAS OUT PRIOR TO USING THEM AND EXPRESSED THE OPINION THAT SHE HAS AN "EXTRA KEEN SENSE OF SMELL." THIS CO SUGGESTED THAT THE CANNULAS BE IMMERSED IN A MIXTURE OF WATER AND VINEGAR PRIOR TO USING THEM. PT EXPRESSED DISSATISFACTION WITH THESE RESPONSES AND SAID THAT THE SUGGESTIONS SHOULD BE PART OF THE LABEL. SHE USES CANNULAS OF VARIOUS LENGTHS. SHE USES THEM FOR PERIODS OF TIME RANGING FROM 2 WKS TO A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL CANNULA CAT DEVILBISS HEALTH CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *