MAUDE Adverse Event Report: Crosstex International Inc Henry Schein; Ultrasoft Earloop Mask

Model Number	104-8073
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports that the masks are giving rashes on the faces of two employees, specifics unknown.The rash was around the mouth and at the chin area.None of the staff members have any known allergies/medical conditions.This happened the first day wearing them, but none of them were seriously injured or required medical attention.
Additional Manufacturer Narrative
Product has not been returned to manufacturer for evaluation.Trend analysis performed.No similar complaints have been recorded for gpluspks, lots 20260401 & 20260114.Device history record has been reviewed, no discrepancies noted.Raw material suppliers contacted; no material changes noted.

• Brand Name: Henry Schein
• Common Device Name: Ultrasoft Earloop Mask
• Manufacturer (Section D): Crosstex International Inc; 6789 w. henrietta road; rush NY 14543
• Manufacturer (Section G): Crosstex International Inc; 6789 w. henrietta road; rush NY 14543
• Manufacturer Contact: katy peterson ; 6789 w. henrietta road; rush, NY 14543
• MDR Report Key: 50820013
• Report Number: 1319130-2026-00008
• Device Sequence Number: 18673904
• Product Code: FXX
• UDI-Device Identifier: 00304040005248
• UDI-Public: (01)00304040005248
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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
• Device Model Number: 104-8073
• Device Catalogue Number: 104-8073
• Device Lot Number: 20260114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown