BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW NASAL MASK

    MDR report key: 15298479 · Received August 25, 2022

    Report

    Report Number
    2020813-2022-00005
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    KHA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PRODUCT IS INDICATED FOR SINGLE USE. THE CLEARVIEW NASAL MASK INSTRUCTIONS FOR USE STATES, "WARNINGS: TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE, USING TITRATION METHOD. PATIENT SHOULD ALWAYS BE CLOSELY MONITORED DURING NITROUS OXIDE USE. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED." A 2-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF CLEARVIEW NASAL MASK, THE PATIENT DEVELOPED REDNESS OF THE FACE. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414449 CLEARVIEW NASAL MASK MASK KHA ACCUTRON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown