BEUDAMED
    FDA Adverse Event Other Summary report: N

    NASAL CANNULA

    MDR report key: 2269433 · Received September 23, 2011

    Report

    Report Number
    2921601-2011-00007
    Event Type
    Other
    Date Received
    September 23, 2011
    Report Date
    September 26, 2011
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) CONTACTED SALTER LABS, VIA THE COMPANY WEB SITE REGARDING A PT WHO SEEMED TO HAVE AN ALLERGIC REACTION WHILE USING NASAL CANNULA PRODUCT 1699-7-50. THE PT'S FACE WAS GETTING RED, SWOLLEN, AND ITCHY WHERE THE TUBING CAME IN CONTACT WITH THE SKIN. (B)(6) STATED THAT "PT RESPONDED POSITIVELY TO BENADRYL. DECREASED REDNESS AFTER REMOVAL OF NASAL CANNULA, WHICH WAS KEPT POST SURGICALLY." (B)(6) REQUESTED INFORMATION REGARDING THE MATERIALS THAT ARE USED TO MAKE PRODUCT. ON (B)(6) 2011, (B)(4) FROM SALTER LABS EMAILED AND INFORMED (B)(6) THAT THE "CANNULA TUBING IS MADE OF PVC, WHICH IS A FORM OF PLASTIC." ALSO (B)(4) REQUESTED THE CANNULA BE RETURNED IF POSSIBLE. NO RESPONSE, NOR PRODUCT RETURNED TO DATE. CURRENT STATUS OF THE PT IS UNKNOWN. THIS IS AN INTERIM REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL CANNULA SALTER STYLE 1600 SERIES CANNULA CAT SALTER LABS 1600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization