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	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the cold pack leaked on the customers sheets onto her pads that she was laying on.Customer informed the cold pack exploded but customer was unable to find a leak.Customer informed the pack was on laying on her leg.Customer does not know if pressure was being applied to the pack or not.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available, this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that the cold pack leaked on the customers sheets onto her pads that she was laying on.Customer informed the cold pack exploded but customer was unable to find a leak.

• 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: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50195858
• Report Number: 1417592-2026-14939
• Device Sequence Number: 15931531
• Product Code: IMD
• UDI-Device Identifier: 10080196158522
• UDI-Public: 10080196158522
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/10/2026

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: 04325100005
• Was Device Available for Evaluation?: No
• 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: 02/23/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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: Female