MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC ULTRA FLUID RESISTANT MASKS 40 PZ

Model Number	GCFCXS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Eye Injury (1845); Eye Pain (4467)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for gcfcxs, lot 20240523.Retention samples were reviewed, no discrepancies noted.Dhr has been reviewed, no discrepancies noted.
Event or Problem Description
While using the mask the wire came out and it scartched the doctor eye.

• Brand Name: ULTRA FLUID RESISTANT MASKS 40 PZ
• Common Device Name: ULTRA FLUID RESISTANT MASKS 40 PZ
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC; 6789 w. henrietta road; rush; NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL, INC; 6789 w. henrietta road; rush; NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w. henrietta road; rush
• MDR Report Key: 20789560
• Report Number: 1319130-2024-00006
• Device Sequence Number: 6764349
• Product Code: FXX
• UDI-Device Identifier: 50732224120015
• UDI-Public: (01)50732224120015
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 20240523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White