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

Model Number	MD-1001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "issue is the packaging is not correctly perforated and then separated to where multiples are still together and not in their individual package form." after review of pictures, it was determined that the perforation may interfere with the sterility seal.
Additional Manufacturer Narrative
We are still attempting to get the device returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Additional Manufacturer Narrative
No samples were able to be returned, however pictures were provided for evaluation.The pictures showed that the perforation location was not cut properly, and it compromised the sterility seal.The cutting blades showed nicks which can stop or interrupt the cutting process.To correct the situation, the operator would swap out the old blades for a new set.This was a set-up error, and inspection is manual and the operator did not catch the mistake.Root cause is manufacturing error, specifically human error by the operator.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MEDLINE FOG INHIBITOR 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: 22796273
• Report Number: 3002750084-2025-00039
• Device Sequence Number: 18303506
• Product Code: OCT
• UDI-Device Identifier: 00840113214822
• UDI-Public: 00840113214822
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K932449
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: MD-1001
• Device Lot Number: 372398
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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