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

Model Number	GCFCXS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that within 3 weeks of using the ultra sensitive earloop mask an employee's face was burning and had blisters.The employee was treated with prednisone.
Additional Manufacturer Narrative
Crosstex spsmedical has contacted the customer requesting additional information regarding the reported event and the status of the employee.To date, we have not received additional information.The ultra sensitive earloop mask is made with a hypoallergenic cellulose inner layer and is latex free.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
The results from the patch test found that the employee is latex sensitive and allergic to 2 rubber accelerators (thiuram mix and black rubber mix).Testing confirmed that there are no rubber accelerators or latex in the ultra sensitive mask components, as confirmed by the suppliers.

• Brand Name: ULTRA SENSITIVE EARLOOP MASK
• Common Device Name: SURGICAL 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 ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14885063
• Report Number: 1319130-2022-00002
• Device Sequence Number: 15023481
• Product Code: FXX
• UDI-Device Identifier: 10732224120017
• UDI-Public: 10732224120017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: GCFCXS
• Device Catalogue Number: GCFCXS
• Device Lot Number: 20191021, 20200124
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown