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

Model Number	DF-3120
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 is in process of being returned, and the investigation is ongoing.Once we have additional relevant information, it wil be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "sterilized failure".
Additional Manufacturer Narrative
The device was returned for evaluation.The root cause is product interfering with the pouch seal, a manufacturing error.The exact cause is unknown, but it may have been an operator error (product not loaded properly, operator not remediating the protruding product fault) or other manufacturing error (curled sponges, light weight product lifting out of pockets due to air flow).If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: DR FOG TREATED SPONGE; 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: 23796410
• Report Number: 3002750084-2025-00067
• Device Sequence Number: 14833301
• Product Code: OCT
• UDI-Device Identifier: 00840113206926
• UDI-Public: 00840113206926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/13/2026

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-3120
• Device Lot Number: 469252, 471748, 476686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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