MAUDE Adverse Event Report: Three Lakes Drive MEDLINE; DBD-ENT PACK

Catalog Number	DYNJ80023
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DBD-ENT PACK
• Manufacturer (Section D): Three Lakes Drive; northfield IL 60093 -275
• Manufacturer Contact: felipe bifareti
• MDR Report Key: 50715672
• Report Number: 1417592-2026-35844
• Device Sequence Number: 13414714
• Product Code: OGR
• UDI-Device Identifier: 40195327007639
• UDI-Public: 40195327007639
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/06/2026

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
• Device Catalogue Number: DYNJ80023
• Device Lot Number: 23EBQ689
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown