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

Model Number	GCFCXSSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Crosstex spsmedical has contacted the customer requesting additional information regarding the reported event and the status of the employees.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.The user facility returned 4 boxes of masks from the same lot subject of the reported event to crosstex spsmedical for evaluation.No issues were noted.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that staff members experienced skin irritation while wearing ultra sensitive earloop face masks.The user facility did not disclose if medical treatment was sought or administered.

• 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 ; 6789 w henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 15820365
• Report Number: 1319130-2022-00006
• Device Sequence Number: 3113310
• Product Code: FXX
• UDI-Device Identifier: 10732224120062
• UDI-Public: 10732224120062
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: GCFCXSSF
• Device Catalogue Number: GCFCXSSF
• Device Lot Number: 20220208
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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