BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 18842480 · Received March 5, 2024

    Report

    Report Number
    3000219639-2024-00020
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    January 18, 2024
    Report Date
    March 5, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    10607411101110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD AN ALLERGIC REACTION.

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD AN ALLERGIC REACTION. THE COMPLAINT OF "FEELING OF HARDNESS AND LACK OF ADHESION OF THE CANNULA TO THE NASAL MUCOSA DURING OXYGEN INTAKE" WERE REPORTED. THERE WERE NO LOT NUMBER TO PERFORM AN INVENTORY ANALYSIS, NO PHOTO IMAGES, OR VIDEOS PROVIDED FOR PRODUCT EVALUATION. THE ROOT CAUSE WAS UNABLE TO BE IDENTIFIED AT THIS TIME. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE FIRST COMPLAINT WITHIN THE 24 MONTHS FOR PART NUMBER (B)(6) "SKIN IRRITATION/REACTION. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    ABUNDANT EPISTAXIS, BREAKING OF NASAL CAPILLARIES.

    Description of Event or Problem · 0

    ABUNDANT EPISTAXIS, BREAKING OF NASAL CAPILLARIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629610 SALTER LABS CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 50' CAT SALTER LABS 1053-50 UNKNOWN 10607411101110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other