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

Model Number	73-GCFCXSSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Crosstex has contacted the customer to obtain additional information regarding the reported event; however, to date we have not received additional information.Crosstex requested that the masks subject of the event be returned for evaluation.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that employees obtained scratches on their faces while wearing ultra sensitive earloop face masks.The user facility did not disclose if medical treatment was sought or administered.
Additional Manufacturer Narrative
The results of the evaluation of the returned masks concluded that no further action was needed.Masks were found to be within specification.No additional issues have been reported.

• 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: 15219015
• Report Number: 1319130-2022-00003
• Device Sequence Number: 15119313
• Product Code: FXX
• UDI-Device Identifier: 20612479229383
• UDI-Public: 20612479229383
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 73-GCFCXSSF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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