MalfunctionOCT
Dr Fog Treated Sponge; Sterile
Received Jul 28, 2026
Report 3002750084-2026-00082 · MDR key 50059657
Device
Generic name
Anti-fog
Manufacturer
Aspen Surgical Products, Inc.Model number
DF-3120Lot number
512199, 512200
Product problems
- Unsealed Device Packaging
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Complainant alleges "Sterilized failure".
Additional Manufacturer Narrative
The device was not returned for evaluation, but pictures of the device were provided and the investigation is ongoing. Once we have additional relevant information it will be submitted in a supplemental report.