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

Model Number	GCFCXS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Local Reaction (2035)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Crosstex received a report through a distributor, henry schein, that one of their customers employees experienced itchiness and redness after wearing the crosstex ultra sensitive earloop mask.It was reported that two dental assistants experienced itchiness and redness and one experienced inflammation and had a reaction where the mask came in contact with the skin around the face and neck area.Crosstex ra followed up with the facility and it was reported that one of the dental assistants sought medical attention from a dermatologist.The dental assistant was diagnosed with dermatitis and prescribed a topical cream for her symptoms.It was reported that the dental assistant who sought medical attention has pre-existing allergies.It was reported that both dental assistants have switched to a different brand of facemasks and are currently fine since they stopped wearing the masks.This complaint will continue being monitored in the crosstex complaint handling system.
Event or Problem Description
Crosstex received a report through a distributor, henry schein, that one of their customers employees experienced itchiness and redness after wearing the crosstex ultra sensitive earloop mask.

• Brand Name: ULTRA SENSITIVE EARLOOP MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick rd; hauppauge NY 11788
• MDR Report Key: 9445723
• Report Number: 2433773-2019-00006
• Device Sequence Number: 2243116
• Product Code: FXX
• UDI-Device Identifier: 10732224120017
• UDI-Public: 10732224120017
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 20190701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/10/2019
• 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