BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIDI FACEMASK

    MDR report key: 11979206 · Received June 10, 2021

    Report

    Report Number
    2182318-2021-00003
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 12, 2021
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    FXX
    PMA / PMN Number
    K100800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR RETURN, BUT WAS NOT RETURNED FOR ANALYSIS. THE RASH APPEARS TO HAVE BEEN A TEMPORARY CONDITION, BUT A CONDITION IN WHICH IT IS BELIEVED THAT IF IT REOCCURS HAS THE POTENTIAL TO LEAD TO MEDICAL INTERVENTION. THE LOT NUMBER WAS NOT PROVIDED. DETAILS REGARDING THE USER ARE UNKNOWN SUCH AS ANY KNOWN ALLERGIES, AGE OR SEX. THE DURATION OF TIME THE DEVICE WAS IN USE FOR IS ALSO UNKNOWN, AS WELL AS IF THIS DEVICE WAS REUSED OR USED FOR THE FIRST TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED FOR RISK AND TRENDS, WITH ACTIONS TAKEN AS APPROPRIATE.

    Description of Event or Problem · 1

    A USER AT A HOSPITAL DEVELOPED A RASH BELIEVED TO BE ASSOCIATED WITH THE MASK EAR LOOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872026 TIDI FACEMASK FACEMASK FXX TIDI PRODUCTS LLC 9030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other