BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC-3PLY-ISO 3 PLY DISPOSABLE MASK

    MDR report key: 10436247 · Received August 20, 2020

    Report

    Report Number
    MW5096163
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 18, 2020
    Manufacturer
    NINGBO YIXIN INTELLIGENTIZED SCIENCE AND TECHNOLOGY
    Product Code
    LYU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 3 PLY MEDICAL MASK THAT WAS SOLD TO MEET ASTM LEVEL 1 REQUIREMENT FAILED TO MEET STANDARDS IN TESTING BY US INDEPENDENT TESTING LAB. THESE MASKS WERE MANUFACTURED BY NINGBO YIXIN INTELLIGENTIZED SCIENCE AND TECHNOLOGY CO. LTD (B)(4) AND IMPORTED TO THE US BY (B)(4). THE DISTRIBUTOR OF THE PRODUCT WAS DOING GOOD WORKS. PRODUCT WAS DISTRIBUTED TO END-USERS BETWEEN APRIL-JUNE 2020. ON (B)(6) 2020 OUR CLIENT INFORMED US OF THE TEST FAILURE AND WE JOINTLY ALERTED THE IMPORTER, (B)(4) AND INDIRECTLY THE MANUFACTURER, THROUGH THEM. DISTRIBUTOR HAS COMMUNICATED THE ISSUE WITH OTHER CLIENTS AND HAS REQUESTED PRODUCTS BE SEGREGATED AND REMOVED FROM FACILITIES FOR REPLACEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899536 GC-3PLY-ISO 3 PLY DISPOSABLE MASK ACCESSORY, SURGICAL APPAREL LYU NINGBO YIXIN INTELLIGENTIZED SCIENCE AND TECHNOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1