BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WESTMED LLC

    MDR report key: 17005511 · Received May 25, 2023

    Report

    Report Number
    2028807-2023-00016
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 25, 2023
    Manufacturer
    WESTMED LLC
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN CANNULA IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING, SORES OR IRRITATIONS MAY RESULT. THIS IS REPORTABLE. THE PATIENT NOSE WAS CAUSED TO BLEED. COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN 4 SIMILAR COMPLAINTS IN THE PREVIOUS 24 MONTHS. INSPECTION OF PRODUCT IN INVENTORY SHOWS ALL PRODUCT IN INVENTORY IS OUT OF SPECIFICATION. NCMR-03164 OPENED TO TRACK FURTHER ACTIONS. RISK(RMA-20017F): R48: LOW OXYGEN DELIVERY - FACEPIECE SIZE DOES NOT FIT PATIENT, INCLUDING NARE LENGTH - S=8, O=1 RPN=8. RPN <25. THEREFORE RISK IS ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN CANNULA IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING, SORES OR IRRITATIONS MAY RESULT. THIS IS REPORTABLE. THE PATIENT NOSE WAS CAUSED TO BLEED.

    Description of Event or Problem · 0

    NARES ARE LONGER THAN NORMAL. PATIENT'S NOSE HAS SORES AND EXPERIENCED BLEEDING DUE TO THE LONG NARES.

    Description of Event or Problem · 0

    NARES ARE LONGER THAN NORMAL. PATIENT'S NOSE HAS SORES AND EXPERIENCED BLEEDING DUE TO THE LONG NARES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666469 WESTMED LLC CSP ADULT CANNULA W/7' TUBING CAT WESTMED LLC R-0556-10,R-0556-5 368881,051022N09

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other