MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. ULTRA FLUID RESISTANT MASK; SURGICAL MASK

Model Number	GCFCXU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Choking (2464)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user facility reported that ear loops on their ultra fluid resistant masks had become unattached.In one instance the ear loop went into an employee's mouth and became lodged in the employee's trachea.The employee was taken to the emergency room.The device was not returned to the manufacturer for investigation and therefore confirmation and root cause of the reported event could not be established.Crosstex will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that ear loops on their ultra fluid resistant masks had become unattached.In one instance the ear loop went into an employee's mouth and became lodged in the employee's trachea.

• Brand Name: ULTRA FLUID RESISTANT MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; happauge NY 11788
• MDR Report Key: 11030081
• Report Number: 2433773-2020-00005
• Device Sequence Number: 667644
• Product Code: FXX
• UDI-Device Identifier: 10732224120086
• UDI-Public: (01)10732224120086
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: GCFCXU
• Device Catalogue Number: GCFCXU
• Device Lot Number: 20200420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other