BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESOURCE DIRECT MASK

    MDR report key: 17692015 · Received September 5, 2023

    Report

    Report Number
    MW5145216
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    July 4, 2023
    Report Date
    August 30, 2023
    Manufacturer
    SAFESOURCE DIRECT
    Product Code
    FXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I STARTED SHOWING SYMPTOMS OF HIVES ALL OVER MY BODY AND DEVELOPING BAD SKIN RASH ON MY FACE AFTER I WORE THE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120870 SAFESOURCE DIRECT MASK MASK, SURGICAL FXX SAFESOURCE DIRECT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention