MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY

Model Number	GCFCXUSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the lot subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.The user facility returned four masks of the same lot number subject of the reported event for evaluation.No issues were noted.The ultra earloop mask w/secure fit mask technology is latex free.No additional issues have been reported.
Event or Problem Description
The user facility reported that a student and instructor experienced rashes and skin irritation while wearing ultra earloop masks w/secure fit mask technology.The user facility did not disclose if medical treatment was sought or administered.
Additional Manufacturer Narrative
It was reported that an employee self-applied a steroid cream to treat the reported skin irritation.No additional issues have been reported.

• Brand Name: ULTRA EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY
• Common Device Name: MASK
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: daniel davy ; 6789 west henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 17137336
• Report Number: 1319130-2023-00006
• Device Sequence Number: 5972048
• Product Code: FXX
• UDI-Device Identifier: 10732224120093
• UDI-Public: 10732224120093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: GCFCXUSF
• Device Catalogue Number: GCFCXUSF
• Device Lot Number: 20221206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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
• Patient Sex: Unknown