MAUDE Adverse Event Report: Crosstex International Inc. UltraTM FogFreeTM Earloop Mask; Mask, Blue, 40/box

Model Number	GCFCX
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Vomiting (2144); Cough (4457)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury

• Brand Name: UltraTM FogFreeTM Earloop Mask
• Common Device Name: Mask, Blue, 40/box
• Manufacturer (Section D): Crosstex International Inc.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer (Section G): Crosstex International Inc.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer Contact: katy peterson ; 6789 w. henrietta rd.; rush, NY 14543 ; +1(800)483-7433
• MDR Report Key: 50952850
• Report Number: 1319130-2026-00009
• Device Sequence Number: 21220355
• Product Code: FXX
• UDI-Device Identifier: 10732224120000
• UDI-Public: (01)10732224120000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GCFCX
• Device Catalogue Number: GCFCX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown