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

Model Number	GCFCXS
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Rash (2033); Reaction (2414)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Crosstex received a report through distributor (b)(4) dental, that a dentist and dental assistant experienced exposure symptoms after wearing the crosstex ultra fluid resistant mask.After applying their masks, they experienced itchiness and redness on their faces.The dental assistant also experienced an itchy throat and tongue.Both users have reported using crosstex ultra fluid resistant mask for several years and this is the first time they have reacted to it.The dentist immediately removed her mask and took benadryl.The dentist felt fine and worked the rest of the day.The dental assistant washed their face following the incident then sought medical attention.The dental assistant was prescribed cortisol cream.Both users have a history of allergies and have since stopped wearing the mask.Both users are reported to be doing fine.This complaint will be monitored in the crosstex complaint handling system.
Event or Problem Description
Crosstex received a report through distributor (b)(4) dental, that a dentist and dental assistant experienced exposure symptoms after wearing the crosstex ultra fluid resistant mask.

• Brand Name: ULTRA FLUID RESISTANT MASKS
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; happauge, ny
• MDR Report Key: 9853460
• Report Number: 2433773-2020-00003
• Device Sequence Number: 11493284
• Product Code: FXX
• UDI-Device Identifier: 10732224120017
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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: GCFCXS
• Device Catalogue Number: GCFCXS
• Device Lot Number: 201912123,20191212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/19/2020
• 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