BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FOGFREE EARLOOP MASK

    MDR report key: 17509026 · Received August 11, 2023

    Report

    Report Number
    1319130-2023-00009
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    August 11, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY REPORTED LOT NUMBERS 20221013, 20221014, 20220927, AND 20221012. THE USER FACILITY DID NOT DISCLOSE WHICH SPECIFIC LOT NUMBERS WERE INVOLVED WITH THE REPORTED EVENT. CROSSTEX SPSMEDICAL HAS REQUESTED CLARIFICATION FROM THE CUSTOMER TO DETERMINE WHICH LOTS WERE INVOLVED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORD OF THE REPORTED LOTS WERE REVIEWED, AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE REPORTED LOTS. CROSSTEX SPSMEDICAL HAS REQUESTED THAT THE ULTRA FOGFREE EARLOOP MASKS BE RETURNED FOR EVALUATION. THE ULTRA FOGFREE EARLOOP MASK IS LATEX FREE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS DISCLOSED THAT EMPLOYEES EXPERIENCED SKIN IRRITATION WITH LOTS 20221013, 20221014, 20220927, AND 20221012. THE USER FACILITY RETURNED SAMPLES FROM EACH LOT FOR EVALUATION. THE EVALUATION DETERMINED THAT SOME OF THE MASKS HAD A FEW RIGID SURFACES. CROSSTEX SPSMEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT STAFF MEMBERS EXPERIENCED SKIN IRRITATION WHILE WEARING ULTRA FOGFREE EARLOOP MASKS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216418 ULTRA FOGFREE EARLOOP MASK MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCX 10732224120000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown