MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER; BLADE, SCALPEL

Model Number	371110
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned for evaluation.Information in this report is based on information provided by a distributor and analysis of manufacturing records.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges, "three blades that were reportedly dull upon use.".

• Brand Name: BARD-PARKER
• Common Device Name: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: rebecca gilbert ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 22786251
• Report Number: 3002750084-2025-00037
• Device Sequence Number: 21299496
• Product Code: GES
• UDI-Device Identifier: 00840113201525
• UDI-Public: 00840113201525
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 371110
• Device Lot Number: 0425683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/12/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown