MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAP CHOLE PACK

Catalog Number	DYNJ84913C
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DBD-LAP CHOLE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50238923
• Report Number: 1417592-2026-16921
• Device Sequence Number: 18728231
• Product Code: FDE
• UDI-Device Identifier: 10198459253430
• UDI-Public: 10198459253430
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/13/2026

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: DYNJ84913C
• Device Lot Number: 25EMI696
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2025
• 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: 08/13/2025
• Initial Report FDA Received Date: 08/13/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown