MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. DR FOG SOLUTION WITH SPONGE; ANTI-FOG

Model Number	DF-3100
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, however pictures of the device were provided and the complaint was confirmed.Based on the photo, it confirms that ribbon from the printer got sealed into the pouch seal.The ribbon can become wrapped around the core, and when the operator attempts to remove the jammed ribbon, pieces of ribbon may fall into the packaging area.The root cause is manufacturing error.This should be considered the final report.If any additinal relevant inforamtion is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "i would like to inform you that during our production process, we identified the presence of particles inside the package of the antifog." note: this report is for the picture which showed a sterility breach (black ribbon through seal).

• Brand Name: DR FOG SOLUTION WITH SPONGE
• Common Device Name: ANTI-FOG
• 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 ; 6166987100
• MDR Report Key: 23360126
• Report Number: 3002750084-2025-00053
• Device Sequence Number: 15671306
• Product Code: OCT
• UDI-Device Identifier: 00840113200597
• UDI-Public: 00840113200597
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K932449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: Other
• Device Model Number: DF-3100
• Device Lot Number: 480464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown