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 device was not returned for evaluation, but the complaint was confirmed based on the picture that was provided.The root cause was manufacturing error.The sample contained a sponge within the package seal.The most probable root cause is related to manual pouch loading and movement of the foam during the sealing process.Light weight sponge material, manual placement of foam into the tray, and a shallow pouch design may all contribute, as well as the foam color closely matching the tyvek material so it can be difficult to detect during manual end-of-line inspection.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: 25337888
• Report Number: 3002750084-2026-00053
• Device Sequence Number: 13293959
• 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): 05/29/2026

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: 499806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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