BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HONGYU DISPOSABLE MEDICAL FACE MASK

    MDR report key: 11071848 · Received December 24, 2020

    Report

    Report Number
    11071848
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD
    Product Code
    KHA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE BOXES CONTAIN MASKS WITH BROKEN EAR LOOPS ON ONE SIDE OF MASK. OTHER MASKS IN BOXES THAT DID NOT ARRIVE BROKEN STARTED TO BREAK WITH STAFF WEARING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535454 HONGYU DISPOSABLE MEDICAL FACE MASK MASK, SCAVENGING KHA ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD 20200403

    Patients

    Seq Age Sex Outcome Treatment
    1