MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ISOLATOR PLUS N95 SURGICAL RESPIRATOR

Model Number	GPRN95
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that students obtained cuts on their noses while wearing isolator plus n95 surgical respirators.The user facility did not disclose if medical treatment was sought or administered.
Additional Manufacturer Narrative
Crosstex has contacted the customer requesting additional information regarding the reported events and the status of the students.To date, we have not received additional information.There have been no other complaints associated with the lot numbers subject of the reported events.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
The user facility returned the isolator plus n95 surgical respirators for evaluation.However, a specific root cause could not be determined.No additional issues have been reported.

• Brand Name: ISOLATOR PLUS N95 SURGICAL RESPIRATOR
• Common Device Name: SURGICAL RESPIRATOR
• 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: 16563966
• Report Number: 1319130-2023-00001
• Device Sequence Number: 12194705
• Product Code: MSH
• UDI-Device Identifier: 10732224000524
• UDI-Public: 10732224000524
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/17/2023

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: GPRN95
• Device Catalogue Number: GPRN95
• Device Lot Number: 2035081, 2103481
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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