MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PACK,COLD,INSTANT,HEAVY-WT,JR,5X7

Catalog Number	MDS138010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, there was an incident with the hot and cold pack mds138010 which resulted in a nurse having a reaction as the pack busted.
Additional Manufacturer Narrative
According to the facility, there was an incident with the hot and cold pack mds138010 which resulted in a nurse having a reaction as the pack busted.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: PACK,COLD,INSTANT,HEAVY-WT,JR,5X7
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 25082931
• Report Number: 1417592-2026-00900
• Device Sequence Number: 13370328
• Product Code: IMD
• UDI-Device Identifier: 10080196158577
• UDI-Public: 10080196158577
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: MDS138010
• Device Lot Number: VN25256
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown