BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY, SURGICAL APPAREL

    MDR report key: 10634847 · Received October 6, 2020

    Report

    Report Number
    10634847
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 23, 2020
    Manufacturer
    GUIZHOU CHIENYEH PHARMACEUTICAL PACKAGING CO.,LTD
    Product Code
    LYU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EAR LOOPS ARE DISCONNECTED WHEN MASK TAKEN FROM BOX, OR LOOPS BREAK THE FIRST TIME STAFF REMOVE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102928 ACCESSORY, SURGICAL APPAREL LYU GUIZHOU CHIENYEH PHARMACEUTICAL PACKAGING CO.,LTD 2020019

    Patients

    Seq Age Sex Outcome Treatment
    1