BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS ETCO2/O2 NASAL CANNULA #4707-13-13

    MDR report key: 12525650 · Received September 23, 2021

    Report

    Report Number
    MW5104182
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 22, 2021
    Manufacturer
    SUNMED HOLDINGS, LLC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS RESEARCHING MEDICATIONS AND DEVICES TO BE USED IN AN UPCOMING PROCEDURE THAT IS SCHEDULED. THE HEALTHCARE PROVIDER LISTED SALTER LABS ETCO2/O2 NASAL CANNULA #4707-13-13 AMONG THE ITEMS. I CHECKED ONLINE AND IT WAS BEING MARKETED AS "LATEX FREE" BUT DID NOT INCLUDE THE APPROVED LABELLING OF "NOT MADE WITH NATURAL RUBBER LATEX" ON ANY OF THE MATERIALS AVAILABLE ONLINE. SO, I CALLED SALTER / SUNMED REGARDING THE ITEM AND RECEIVED A VOICEMAIL RESPONSE AFTER REQUESTING LATEX INFORMATION VIA THE ONLINE-PROVIDED PHONE NUMBER. THE MANUFACTURER RESPONDED VIA VOICEMAIL THAT NATURAL RUBBER LATEX IS USED IN THE MANUFACTURING OF THIS PRODUCT. SO, THEY ARE MARKETING AS LATEX FREE EVEN THOUGH NRL IS USED IN MANUFACTURING, WHICH COULD CAUSE SIGNIFICANT HARM TO LATEX ALLERGIC INDIVIDUALS, INCLUDING MYSELF. I SPOKE WITH SOMEONE NAMED (B)(6) INITIALLY. SHE REACHED OUT VIA EMAIL TO SOMEONE NAMED (B)(6). THEN THE VOICEMAIL WAS LEFT BY (B)(6) AGAIN, READING DIRECTLY FROM WHAT SHE RECEIVED IN RESPONSE TO HER INQUIRY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421121 SALTER LABS ETCO2/O2 NASAL CANNULA #4707-13-13 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK SUNMED HOLDINGS, LLC. 4707-13-13

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR