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

Model Number	GCFCXU
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); Red Eye(s) (2038)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that when wearing crosstex ultra face masks, they experienced eye redness and skin burning under the mask.
Additional Manufacturer Narrative
Crosstex received a report that a customer experienced eye redness and skin burning when wearing crosstex ultra face masks.Crosstex followed up with the facility in which this occurred, but was not able to make contact with the end user.There are no details regarding lasting symptoms or current condition of the end user.There have been no other reports of reactions to this mask at the dental facility.The facility did not identify the lot number nor return product for quality analysis.

• Brand Name: ULTRA EARLOOP MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 12206979
• Report Number: 2433773-2021-00002
• Device Sequence Number: 20115664
• Product Code: FXX
• UDI-Device Identifier: 10732224120086
• UDI-Public: 10732224120086
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1