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
Event or Problem Description
Complainant alleges "sterilized failure".
Additional Manufacturer Narrative
The actual device was returned for evaluation.There was product interference, preventing a proper seal on the package and resulting in a seal failure.The sponge undergoes pre-treatment and drying in the oven, which can lead to curling of the liner on the back of the sponge.If the liner curls upward higher than the pouch, the sponge may interfere with the maching, potentially being pushed in the sealing lane and becoming sealed with the package.The high speed cycle time of the packaging line does not allow the operator sufficient time to detect and remove curled sponges before packaging.Work instruction updates now include visual guidance on identifying curled sponges and instructions for removal before pouch loading.Additionally as of march 19.2025, the cycle time has been reduced to provide operators more time for inspection and to prevent curled sponges from interfering with the seal.The root cause is manufacturing error.This should be considered the final report.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: 21710432
• Report Number: 3002750084-2025-00010
• Device Sequence Number: 15970506
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: 432257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/27/2025
• 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