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

Catalog Number	MDS138007
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "medline infant heel warmers (9.5cm x 14cm) x2 got cold instead of hot when activated per instructions.".
Additional Manufacturer Narrative
The customer reported that two medline infant heel warmers got cold instead of hot when activated per instructions, and the customer confirmed they followed troubleshoot steps and did not fix issue.Medline did not receive a sample, photo, or video; finished good/component trending was performed with no trends identified, quality control inspection records were reviewed but could not be located, and pcn history was reviewed with no product changes identified that could have contributed to the alleged product failure.The investigation results were not confirmed.The cause was documented as sample required to determine cause, and the division will monitor complaints through quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.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.

• Brand Name: MEDLINE
• Common Device Name: WARMER,HEEL,INFANT,GEL PK,100CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913183
• Report Number: 1417592-2026-51786
• Device Sequence Number: 5344756
• Product Code: MPO
• UDI-Device Identifier: 10080196719655
• UDI-Public: 10080196719655
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040856
• 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): 09/25/2026

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: MDS138007
• Device Lot Number: VN24286A29
• Was Device Available for Evaluation?: Yes
• 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: 09/18/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown