MAUDE Adverse Event Report: Medline Industries LP Medline; MAJOR ABDOMINAL SETUP PACK-LF

Catalog Number	DYNJ26872N
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: MAJOR ABDOMINAL SETUP PACK-LF
• Manufacturer (Section D): Medline Industries LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: michael crook ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50885259
• Report Number: 1417592-2026-50155
• Device Sequence Number: 10664295
• Product Code: LRO
• UDI-Device Identifier: 10198459246661
• UDI-Public: 10198459246661
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: DYNJ26872N
• Device Lot Number: 26EBT073
• Was Device Available for Evaluation?: Yes
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown