BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURE MASK ASTM LEVEL 2 BLUE ADULT

    MDR report key: 17079250 · Received June 7, 2023

    Report

    Report Number
    1319130-2023-00005
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 7, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    00304040005200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY RETURNED TWO BOXES OF PROCEDURE MASKS ASTM LEVEL 2 BLUE ADULT FOR EVALUATION. NO ISSUES WERE IDENTIFIED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THE MASKS OF THE SAME LOT NUMBER SUBJECT OF THE REPORTED EVENT WILL BE RETURNED FOR EVALUATION. THE PROCEDURE MASKS ASTM LEVEL 2 BLUE ADULT ARE LATEX FREE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT EMPLOYEES AND PATIENTS EXPERIENCED RASHES AND SKIN IRRITATION WHILE WEARING PROCEDURE MASKS ASTM LEVEL 2 BLUE ADULT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330134 PROCEDURE MASK ASTM LEVEL 2 BLUE ADULT MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCPBLS 20230203 00304040005200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown