MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER ® CARBON RIB-BACK BLADES; BLADE, SCALPEL

Model Number	371115
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Discoloration on blades during procedure and after use.

• Brand Name: BARD-PARKER ® CARBON RIB-BACK BLADES
• Common Device Name: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive s.e; caledonia MI 49316
• MDR Report Key: 22850592
• Report Number: 22850592
• Device Sequence Number: 4419490
• Product Code: GES
• UDI-Device Identifier: 00840113201761
• UDI-Public: (01)00840113201761
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2025
• Report Date (Section F): 08/13/2025

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
• Device Model Number: 371115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 08/13/2025