BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY

    MDR report key: 17137336 · Received June 15, 2023

    Report

    Report Number
    1319130-2023-00006
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    10732224120093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE USER FACILITY RETURNED FOUR MASKS OF THE SAME LOT NUMBER SUBJECT OF THE REPORTED EVENT FOR EVALUATION. NO ISSUES WERE NOTED. THE ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY IS LATEX FREE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EMPLOYEE SELF-APPLIED A STEROID CREAM TO TREAT THE REPORTED SKIN IRRITATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A STUDENT AND INSTRUCTOR EXPERIENCED RASHES AND SKIN IRRITATION WHILE WEARING ULTRA EARLOOP MASKS W/SECURE FIT MASK TECHNOLOGY. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838297 ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCXUSF 20221206 10732224120093

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown