MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MEDLINE ANTI-FOG (EU), STERILE

Model Number	MD-1001E
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation.The investigation is ongoing.Once additional relevant information is available, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "when used on the sponge, the anti-fogging agent foams up, which actually reduces visibility.".
Additional Manufacturer Narrative
The product was returned for evaluation.A functional inspection was completed using the returned product samples and all inspections passed requirements.A dhr review was completed and determined that all inspections passed and no nonconformances were created during the manufacturing of this lot.As the solution passed all tests, the complaint could not be confirmed and no root cause could be determined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MEDLINE ANTI-FOG (EU), STERILE
• 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: 23402678
• Report Number: 3002750084-2025-00052
• Device Sequence Number: 10039055
• Product Code: OCT
• UDI-Device Identifier: 00840113214822
• UDI-Public: 00840113214822
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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-1001E
• Device Lot Number: 446216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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