MAUDE Adverse Event Report: Aspen Surgical Products, Inc Precept Mask; Surgical; Lite & Cool; Blue; ASTM Level 1; Non-Sterile; Surgical Mask

Model Number	15200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Local Reaction (2035); Cough (4457)
Type of Reportable Event	Malfunction

• Brand Name: Precept Mask; Surgical; Lite & Cool; Blue; ASTM Level 1; Non-Sterile
• Common Device Name: Surgical Mask
• 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: 50253731
• Report Number: 3002750084-2026-00087
• Device Sequence Number: 10141631
• Product Code: FXX
• UDI-Device Identifier: 10814707020080
• UDI-Public: 10814707020080
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K770463
• 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): 08/14/2026

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: 15200
• Device Lot Number: Unknown
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• 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