BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY

    MDR report key: 16914633 · Received May 11, 2023

    Report

    Report Number
    1319130-2023-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Report Date
    May 11, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX SPSMEDICAL HAS CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. TO DATE, WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. THE ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY IS LATEX FREE. 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 EMPLOYEES EXPERIENCED SKIN IRRITATION WHILE WEARING ULTRA EARLOOP MASKS W/SECURE FIT MASK TECHNOLOGY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053288 ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCXUSF 10732224120093

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown