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

Model Number	GCFCX
Medical Device Problem Codes	Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported lot numbers 20221013, 20221014, 20220927, and 20221012.The user facility did not disclose which specific lot numbers were involved with the reported event.Crosstex spsmedical has requested clarification from the customer to determine which lots were involved with the reported event.The device history record of the reported lots were reviewed, and no abnormalities were noted.There have been no other complaints associated with the reported lots.Crosstex spsmedical has requested that the ultra fogfree earloop masks be returned for evaluation.The ultra fogfree earloop mask is latex free.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that staff members experienced skin irritation while wearing ultra fogfree earloop masks.The user facility did not disclose if medical treatment was sought or administered.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was disclosed that employees experienced skin irritation with lots 20221013, 20221014, 20220927, and 20221012.The user facility returned samples from each lot for evaluation.The evaluation determined that some of the masks had a few rigid surfaces.Crosstex spsmedical will continue to monitor for similar events.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: 17509026
• Report Number: 1319130-2023-00009
• Device Sequence Number: 20468621
• Product Code: FXX
• UDI-Device Identifier: 10732224120000
• UDI-Public: 10732224120000
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/11/2023

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
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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