MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ULTRA FOGFREE EARLOOP MASK

Model Number	GCFCX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rash (2033)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that two employees experienced a rash on their face while wearing ultra fogfree earloop masks.No medical treatment was sought or administered.
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.Crosstex has requested that the ultra fogfree earloop masks be returned for evaluation.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The user facility returned the ultra fog free earloop masks for evaluation.No issues were noted.The ultra fog free earloop mask is made with a hypoallergenic cellulose inner layer and is latex free.No additional issues have been reported.

• Brand Name: ULTRA FOGFREE EARLOOP MASK
• 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: 16781568
• Report Number: 1319130-2023-00002
• Device Sequence Number: 12430000
• Product Code: FXX
• UDI-Device Identifier: 10732224120000
• UDI-Public: 10732224120000
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/20/2023

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: GCFCX
• Device Catalogue Number: GCFCX
• Device Lot Number: 20221019
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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