BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FACE MASK

    MDR report key: 11628785 · Received April 6, 2021

    Report

    Report Number
    MW5100598
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 4, 2021
    Manufacturer
    ZHEJIANG AMINDX BIOTECHNOLOGY CO
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS SHOPPING AT (B)(6) AND OF COURSE WAS WEARING A MASK BECAUSE IT IS THE STORE'S POLICY (I WEAR THE BLUE DISPOSABLE KIND). I AM A VERY HEALTHY PERSON, BUT BECAME VERY SHORT OF BREATH AND A BIT ANXIOUS BECAUSE OF MY BREATHING DIFFICULTY. I REMOVED MY MASK, AND AFTER A COUPLE OF DEEP BREATHS, I FULLY RECOVERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522975 DISPOSABLE FACE MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR ZHEJIANG AMINDX BIOTECHNOLOGY CO GB/T32610-2016 4400001563

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other