MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WARMER,HEEL,INFANT,GEL PK,100CS

Catalog Number	MDS138007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, a heel warmer appeared to have leaked onto infant's right heel.The customer stated that upon further assessment, the heel "appeared to be red, painful to touch, sloughing skin and weepy.".The customer said that the total application time of the warmer was 3 to 5 minutes.The customer reported that a wound rn and the burn team were consulted for treatment and follow-up care.It has been determined that the reported event caused or contributed to serious injury, therefore, 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 customer, on (b)(6) 2025, a heel warmer appeared to have leaked onto infant's right heel.The customer stated that upon further assessment, the heel "appeared to be red, painful to touch, sloughing skin and weepy.".

• Common Device Name: WARMER,HEEL,INFANT,GEL PK,100CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22809547
• Report Number: 1417592-2025-00387
• Device Sequence Number: 20792682
• Product Code: MPO
• UDI-Device Identifier: 10080196719655
• UDI-Public: 10080196719655
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: MDS138007
• Device Lot Number: VN24333A9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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 Age: 2 MO
• Patient Sex: Female
• Patient Weight: 5 KG