BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLNICE

    MDR report key: 21449278 · Received February 24, 2025

    Report

    Report Number
    MW5166756
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 20, 2025
    Manufacturer
    SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS DEVICE IS CONCERNING FOR ANY PARENT USING TO SAVE A CHILD FROM CHOKING. THIS PRODUCT CAN BE PULLED APART BY THE MASK AND BELLO, AND LOOKS IT IS BEING HELD TOGETHER BY TOXIC GLUE. NOT ONLY IS THE MASK GLUED ON BUT THE BOTTOM OF THE BELLO IS ALSO GLUED ON. VERY CONCERNING CONSIDERING I HAVE A 7 MONTH OLD AND DO NOT WANT HER INHALING TOXIC GLUE. HTTPS://WILLNICE.NET/ IS WHERE THIS PRODUCT IS SOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636996 WILLNICE APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female