BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT NASAL CANNULA

    MDR report key: 2417638 · Received May 5, 2011

    Report

    Report Number
    2921601-2011-00003
    Event Type
    Other
    Date Received
    May 5, 2011
    Report Date
    May 4, 2011
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT, (B)(6), REPORTED VIA THE COMPANY WEBSITE THAT HE HAD AN ALLERGIC REACTION TO THE SALTER CANNULA, WHERE HE HAD A RASH ON EARS, NECK AND CHEEKS. SALTER LABS TECHNICAL PRODUCT SPECIALIST SPOKE WITH THE PT AND FOUND OUT THAT THE PT UNDERWENT AN ALLERGY TEST WHEREBY CANNULAS FROM VARIOUS MANUFACTURES WERE TAPED TO THE PT'S BACK. ALL CANNULAS (REGARDLESS OF MFR) PRODUCED AN ALLERGIC REACTION. THIS SUGGESTED THAT THE PT HAS A PVC ALLERGY. THE TECHNICAL PRODUCT SPECIALIST SUGGESTED A DIFFERENT CONFIGURATION OF SALTER CANNULA, WHICH HAS LESS SKIN EXPOSURE. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT NASAL CANNULA 7' ADULT NASAL CANNULA CAT SALTER LABS 1600-7-50 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other