MAUDE Adverse Event Report: Medline Industries, LP Medline; PACK,COLD,INSTANT,HEAVY-WEIGHT,6X10

Catalog Number	MDS138000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: PACK,COLD,INSTANT,HEAVY-WEIGHT,6X10
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50000469
• Report Number: 1417592-2026-07548
• Device Sequence Number: 10435564
• Product Code: IMD
• UDI-Device Identifier: 10080196158522
• UDI-Public: 10080196158522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/a
• 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): 07/22/2026

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: MDS138000
• Device Lot Number: 04325010001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (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