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

Catalog Number	MDS138007H
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: WARMER,HEEL,INFANT,GEL PK,EACH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: camilla allen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50176016
• Report Number: 1417592-2026-13963
• Device Sequence Number: 13233322
• Product Code: MPO
• UDI-Device Identifier: 10080196719655
• UDI-Public: 10080196719655
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 08/06/2026

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: MDS138007H
• Device Lot Number: VN25169A9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2025
• 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: 11/13/2025
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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