MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. ULTRATM EARLOOP MASK; MASK, WHITE, 50/BOX

Model Number	GCFCXS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for gcfcxs, lot 20250915.Device history record has been reviewed, no discrepancies noted.Retention samples have been reviewed, no discrepancies noted.
Event or Problem Description
Distributor reports that customer stated the mask caused skin irritation and had a rougher texture.

• Brand Name: ULTRATM EARLOOP MASK
• Common Device Name: MASK, WHITE, 50/BOX
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w. henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 24314022
• Report Number: 1319130-2026-00001
• Device Sequence Number: 4942299
• Product Code: FXX
• UDI-Device Identifier: 10732224120017
• UDI-Public: (01)10732224120017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: GCFCXS
• Device Catalogue Number: GCFCXS
• Device Lot Number: 20250915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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: Other
• Patient Sex: Unknown