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

Catalog Number	MDS138010
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the cold pack burst into the hands of a provider while she was attempting to activate the cold pack.She followed the instructions on the outside of the package.The pack popped completely, and all the inside contents exploded out into the air bursting out of the outer plastic bag.The contents got onto the skin and eyes of the provider.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 burst into the hands of a provider while she was attempting to activate the cold pack.

• 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: urmi parekh ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25703346
• Report Number: 1417592-2026-04056
• Device Sequence Number: 13198478
• Product Code: IMD
• UDI-Device Identifier: 40080196158578
• UDI-Public: 40080196158578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2026

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: 48823050001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/03/2026
• 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