MAUDE Adverse Event Report: Aspen Surgical Products, Inc. Precept Mask; Procedure; FluidGard 160 Anti-Fog; Blue Diamond; ASTM Level 3; Non; Surgical Masks

Model Number	15301
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Asthma (1726)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures of the device were provided.The investigation reviewed manufacturing records, materials, biocompatability documentation, supplier information, and additional testing and usage conditions.No evidence was found of a deviation, material change, or any other concerns.The root cause could not be determined.If any additional relevant information is identified it will be submitted in a supplemental reprot.

• Brand Name: Precept Mask; Procedure; FluidGard 160 Anti-Fog; Blue Diamond; ASTM Level 3; Non
• Common Device Name: Surgical Masks
• Manufacturer (Section D): Aspen Surgical Products, Inc.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; +1(616)698-7100
• MDR Report Key: 50568545
• Report Number: 3002750084-2026-00094
• Device Sequence Number: 13382694
• Product Code: FXX
• UDI-Device Identifier: 10814707020219
• UDI-Public: 10814707020219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K771409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15301
• Device Lot Number: 510316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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