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 was just returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "sterilized failure".
Additional Manufacturer Narrative
The actual device was returned for evaluation.After review of the sample, it was clear that product was caught in the seal, interfering with the seal process and preventing a complete seal.The most common cause is the sponge can shift while in the pouch prior to the pouch being sealed.The root cause is manufacturing error.If any additional relevant information is identified, it will be submitted in as 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: 22906049
• Report Number: 3002750084-2025-00042
• Device Sequence Number: 9089228
• 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): 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: Other
• Device Model Number: DF-3120
• Device Lot Number: 457918, 459017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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