BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FOGFREE EARLOOP MASK

    MDR report key: 16781568 · Received April 20, 2023

    Report

    Report Number
    1319130-2023-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Report Date
    April 20, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    10732224120000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF THE LOT SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. CROSSTEX HAS REQUESTED THAT THE ULTRA FOGFREE EARLOOP MASKS BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY RETURNED THE ULTRA FOG FREE EARLOOP MASKS FOR EVALUATION. NO ISSUES WERE NOTED. THE ULTRA FOG FREE EARLOOP MASK IS MADE WITH A HYPOALLERGENIC CELLULOSE INNER LAYER AND IS LATEX FREE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED A RASH ON THEIR FACE WHILE WEARING ULTRA FOGFREE EARLOOP MASKS. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461369 ULTRA FOGFREE EARLOOP MASK MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCX 20221019 10732224120000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown