MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. CROSSTEX ULTRA SENSITIVE EARLOOP; CROSSTEX SURGICAL MASK

Model Number	GCFCXS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Crosstex received a report through a distributor, (b)(6), that one of their customer's employees experienced rashes after wearing ultra fluid resistant masks.It was reported that four assistants in the dental office experienced a rash where the mask was sitting on their faces.Crosstex ra followed up with the facility and it was reported that two of the four dental assistants sought medical attention from a dermatologist and they were prescribed topical antibiotics.The other two dental assistants did not seek medical attention, but stopped wearing the masks and their rashes cleared.It was reported that the dental assistants are currently fine since they stopped wearing the masks.The facility reported that the two dental assistants who sought medical attention do not have pre-existing allergies.This complaint will continue to be monitored in the crosstex complaint handling system.
Event or Problem Description
Crosstex received a report through a distributor, (b)(6), that one of their customer's employees experienced rashes after wearing ultra fluid resistant masks.

• Brand Name: CROSSTEX ULTRA SENSITIVE EARLOOP
• Common Device Name: CROSSTEX SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 9224368
• Report Number: 2433773-2019-00005
• Device Sequence Number: 16260658
• Product Code: FXX
• UDI-Device Identifier: 10732224120024
• UDI-Public: 10732224120024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: 20190624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2019
• 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