MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PACK, COLD, STANDARD,OB-PAD,4.5X14.25

Catalog Number	MDS138055
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: PACK, COLD, STANDARD,OB-PAD,4.5X14.25
• Manufacturer (Section D): Medline Industries, LP; three lakes dr; northfield IL 60093 -275
• Manufacturer Contact: shelena smoke-wyche ; three lakes dr; northfield, IL 60093--275
• MDR Report Key: 50692646
• Report Number: 1417592-2026-09753
• Device Sequence Number: 17621060
• Product Code: IMD
• UDI-Device Identifier: 00080196733715
• UDI-Public: 00080196733715
• 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): 09/09/2026

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: MDS138055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown