BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY

    MDR report key: 17226103 · Received June 29, 2023

    Report

    Report Number
    1319130-2023-00007
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    10732224120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND THE STATUS OF THE EMPLOYEES. TO DATE, WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. 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. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED SCRATCHES ON THEIR FACES WHILE WEARING ULTRA SENSITIVE 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
    264754 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