MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. CRITERION SEN SKIN EARLOOP MASK L3 BLUE

Model Number	GCFCXSBLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for gcfcxsbls, lot 20250904.Dhr has been reviewed, no discrepancies noted.
Event or Problem Description
A nurse experienced temporary redness on the nose after wearing the mask with the blue side facing outward.The nurse had used this mask type before inside out without issues, reported no known allergies, no broken skin and required no medical treatment or follow-up.
Additional Manufacturer Narrative
The device subject of the reported event was returned to crosstex for evaluation, no discrepanies were noted.No further action will be taken at this time.

• Brand Name: CRITERION SEN SKIN EARLOOP MASK L3 BLUE
• Common Device Name: MASK
• 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: stephanie wasielewski ; 6789 w. henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 24072255
• Report Number: 1319130-2025-00015
• Device Sequence Number: 9113447
• Product Code: FXX
• UDI-Device Identifier: 00304040168950
• UDI-Public: (01)00304040168950
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K082258
• 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,Followup
• Report Date (Section B): 02/17/2026

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: GCFCXSBLS
• Device Catalogue Number: GCFCXSBLS
• Device Lot Number: 20250904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown