BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLNICE

    MDR report key: 21708901 · Received March 27, 2025

    Report

    Report Number
    3016674860-2025-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 3, 2025
    Report Date
    March 14, 2025
    Manufacturer
    SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE, SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD, HEREBY SUBMIT A DETAILED EXPLANATION REGARDING THE VOLUNTARY MEDWATCH MDR REPORT (CASE NO. MW5166756). WE ARE ACUTELY AWARE OF THE SIGNIFICANCE OF PRODUCT QUALITY AND SAFETY. IN RESPONSE TO THE CONCERNS RAISED BY THE REPORTER, WE HAVE TAKEN THEM VERY SERIOUSLY AND HAVE PROMPTLY LAUNCHED A COMPREHENSIVE INVESTIGATION AND ANALYSIS. WE ARE NOW PRESENTING THE RELEVANT DETAILS TO YOU AS FOLLOWS: EVENT BACKGROUND AND INITIAL INVESTIGATION ON (B)(6) 2025, WE RECEIVED THE VOLUNTARY MEDWATCH MDR (MW5166756) FROM A FEMALE REPORTER. SHE CLAIMED THAT THE BELLO AND MASK OF OUR PRODUCT COULD BE PULLED APART AND EXPRESSED CONCERNS THAT THE ADHESIVE USED MIGHT BE TOXIC, POSING A RISK TO HER 7-MONTH-OLD INFANT. WE IMMEDIATELY INITIATED AN INVESTIGATION. THE REPORTER PURCHASED A PREVIOUS-GENERATION PRODUCT, WHICH UTILIZED THE FOLLOWING MANUFACTURING PROCESS: THE BELLO HAS A BASE PLATE WITH A ROUND HOLE IN THE CENTER. THE MASK HAS A CYLINDRICAL TUBE INTERFACE ON THE TOP. THE MASK AND BELLO ARE CONNECTED BY INSERTING THE OUTER PERIPHERY OF THE CYLINDRICAL TUBE INTERFACE ON THE TOP OF THE MASK INTO THE ROUND HOLE OF THE BELLO'S BASE PLATE. ADHESIVE IS APPLIED TO THE CONNECTION AREA BETWEEN THE OUTER PERIPHERY OF THE MASK'S CYLINDRICAL TUBE INTERFACE AND THE BASE PLATE OF THE BELLO TO FURTHER SECURE THE CONNECTION. AFTER CONDUCTING A COMPREHENSIVE REVIEW OF THE PRODUCT DESIGN, MANUFACTURING PROCESS, AND INSTRUCTIONS FOR USE, WE BELIEVE THAT THE SEPARATION OF THE BELLO AND MASK IS MOST LIKELY CAUSED BY EXTERNAL FORCES APPLIED TO THE PRODUCT. DETAILED EXPLANATION ON ADHESIVE SAFETY 1. ADHESIVE SELECTION STANDARDS WE STRICTLY REQUIRE ALL ADHESIVES TO COMPLY WITH BIOCOMPATIBILITY STANDARDS AND FDA 21 CFR 177.2600. THEREFORE, THE ADHESIVE USED IN THE PREVIOUS-GENERATION PRODUCT (THE VERSION RECEIVED BY THE REPORTER) IS BIOLOGICALLY SAFE. 2. ADHESIVE APPLICATION AND HUMAN CONTACT ADHESIVE IS APPLIED TO THE CONNECTION AREA BETWEEN THE OUTER PERIPHERY OF THE MASK'S CYLINDRICAL TUBE INTERFACE AND THE BASE PLATE OF THE BELLO TO FURTHER SECURE THE CONNECTION. DURING NORMAL USE, THE USER COMES INTO CONTACT WITH THE AREA OPPOSITE TO THE ADHESIVE (NAMELY, THE INNER REGION OF THE MASK), WHICH IS PHYSICALLY SEPARATED FROM THE ADHESIVE. THIS DESIGN ENSURES THAT THE USER WILL NOT COME INTO DIRECT CONTACT WITH THE ADHESIVE. BASED ON THE ABOVE, WE BELIEVE THIS INCIDENT DOES NOT QUALIFY AS AN ADVERSE EVENT. COMMUNICATION WITH THE REPORTER: FOLLOWING RECEIPT OF THE MDR, WE PROACTIVELY ATTEMPTED TO CONTACT THE REPORTER VIA EMAIL ON (B)(6)2025, TO ADDRESS HER CONCERNS AND OFFER ASSISTANCE. HOWEVER, REGRETTABLY, WE DID NOT RECEIVE ANY RESPONSE YET. WE HAVE ALWAYS BEEN WILLING TO MAINTAIN OPEN AND TRANSPARENT COMMUNICATION WITH OUR USERS TO ADDRESS THEIR CONCERNS AND ISSUES. PRODUCT PROCESS IMPROVEMENT AND OPTIMIZATION (B)(6) 2024, WE HAVE DISCONTINUED ADHESIVE USE AND ADOPTED AN ASSEMBLY METHOD RELYING ON FRICTION TO SECURE THE MASK AND BELLO. THE PRIMARY REASON FOR MAKING THIS CHANGE IS THAT ELIMINATING ADHESIVE APPLICATION CAN REDUCE MANUAL LABOR. POST-UPGRADE VALIDATION CONFIRMED THAT THIS OPTIMIZATION MAINTAINS EQUIVALENT NEGATIVE PRESSURE AND AIRFLOW PERFORMANCE WHILE PROVIDING STRONG ADHESION BETWEEN COMPONENTS. CONCLUSION AND COMMITMENT: WE HAVE THOROUGHLY INVESTIGATED THIS MATTER AND PROVIDED EVIDENCE-BASED CLARIFICATIONS. WE SINCERELY HOPE THIS RESPONSE ALLEVIATES THE REPORTER'S CONCERNS. WE PLEDGE TO CONTINUOUSLY MONITOR PRODUCT QUALITY, OPTIMIZE DESIGNS, AND ADDRESS USER FEEDBACK.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE RECEIVED THE VOLUNTARY MEDWATCH MDR (MW5166756) FROM A FEMALE REPORTER. SHE CLAIMED THAT THE BELLO AND MASK OF OUR PRODUCT COULD BE PULLED APART AND EXPRESSED CONCERNS THAT THE ADHESIVE USED MIGHT BE TOXIC, POSING A RISK TO HER 7-MONTH-OLD INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604071 WILLNICE AIRWAY ASSIST DEVICE GCX SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD. FQ-WL01/FQ-WL02

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Female