MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL ULTRATM SENSITIVE FOGFREETM EARLOOP MASK W/ SECURE FITTM; MASK, SURGICAL

Model Number	GCFCXSSF
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three masks were sent back without a box.No lot code was provided.The binder material strip was off center and did not get welded.Similar complaints have been recorded within the past year for gcfcxssf, an investigation into the root cause has been initiated.
Event or Problem Description
The distributor, (b)(4), reported that the metal strip over the nose comes off.A staff member was struck with the metal piece.Staff member went to optometrist for scraped sclera.

• Brand Name: ULTRATM SENSITIVE FOGFREETM EARLOOP MASK W/ SECURE FITTM
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 west henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 21867759
• Report Number: 1319130-2025-00002
• Device Sequence Number: 20805397
• Product Code: FXX
• UDI-Device Identifier: 10732224120062
• UDI-Public: (01)10732224120062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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: GCFCXSSF
• Device Catalogue Number: GCFCXSSF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female