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 "sterilization failure".
Additional Manufacturer Narrative
The devices are in process of being returned for evaluation.Please note that this report covers 6 lots of product (441972, 446445, 440498, 441971, 445268, 447389) with the same malfunction (sterile seal breach) and all were discovered at our distributor during inspection.Investigation is ongoing.Once we have additional relevant information, it will be submitted in s supplemental report.
Additional Manufacturer Narrative
The devices were returned for evaluation.After evaluation, it was clear that product was caught in the seal, causing a seal failure.During pre-treatment and oven drying, the df-3120 sponge can curl due to liner deformation, increasing its veritcal height.If it curls above the pouch height, it can interfere with the sealing mechanism and get sealed in the pouch.Due to previous concerns regarding similar issues, the work instructions have been updated with visual aids and removal steps for curled sponges.This will help reduce future seal related concerns.The root cause was manufacturing error.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: 22109848
• Report Number: 3002750084-2025-00021
• Device Sequence Number: 17960850
• 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): 06/24/2025

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: 441972, 445445, 440498, 441971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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