MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INSTANT HOT PACKS; PACK,HOT,INSTANT,MED ,6X6"

Catalog Number	200697030
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, a patient requested a heat pack.While attempting to activate, one package ruptured, spilling powder on the patient.The patient had irritation to the chest, abdomen, and hand.The loose powder was wiped off with a dry paper towel and then the patient was irrigated (showered) for 30 minutes afterwards.Shortly after, the patient reported itching to skin.The md was notified.The symptoms improved afterwards but the patient still complained of some itching and was given iv benadryl.There were no further skin issues or concerns.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.
Event or Problem Description
According to the facility, a patient requested a heat pack.While attempting to activate, one package ruptured, spilling powder on the patient.The patient had irritation to the chest, abdomen, and hand.

• Brand Name: MEDLINE INSTANT HOT PACKS
• Common Device Name: PACK,HOT,INSTANT,MED ,6X6"
• 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: 23711207
• Report Number: 1417592-2025-00681
• Device Sequence Number: 21512876
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 200697030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown