BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY

    MDR report key: 18190129 · Received November 22, 2023

    Report

    Report Number
    1319130-2023-00013
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Report Date
    November 22, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    10732224120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY IS MADE WITH A HYPOALLERGENIC CELLULOSE INNER LAYER AND IS LATEX FREE. THE MASKS WERE DISCARDED AND CANNOT BE RETURNED TO CROSSTEX SPSMEDICAL FOR EVALUATION. THE LOT NUMBER OF THE MASKS SUBJECT OF THE REPORTED EVENT WAS NOT PROVIDED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A RASH ON THEIR FACE AFTER WEARING AN ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY. THE EMPLOYEE WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723366 ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCXSSF 10732224120062

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown