MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. PROCEDURE MASK ASTM LEVEL 2 BLUE ADULT

Model Number	GCPBLS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that employees and patients experienced rashes and skin irritation while wearing procedure masks astm level 2 blue adult.No medical treatment was sought or administered.
Additional Manufacturer Narrative
The customer stated that the masks of the same lot number subject of the reported event will be returned for evaluation.The procedure masks astm level 2 blue adult are latex free.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 when additional information becomes available.
Additional Manufacturer Narrative
The user facility returned two boxes of procedure masks astm level 2 blue adult for evaluation.No issues were identified.No additional issues have been reported.

• Brand Name: PROCEDURE MASK ASTM LEVEL 2 BLUE ADULT
• 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: 17079250
• Report Number: 1319130-2023-00005
• Device Sequence Number: 6259831
• Product Code: FXX
• UDI-Device Identifier: 00304040005200
• UDI-Public: 00304040005200
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/07/2023

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: GCPBLS
• Device Catalogue Number: 1047799
• Device Lot Number: 20230203
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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