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

Catalog Number	MDS138007
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Paresthesia (4421)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "she went to break the packet so it would heat up and it \"exploded all over a nurse colleague\" of hers.".
Additional Manufacturer Narrative
The customer stated that she went to break the packet so it would heat up and it "exploded all over a nurse colleague" of hers; she said that the nurse felt tingly all over and they called poison experts and they told her to go home and shower and wash everything out of her skin and hair.Sample and/or photo provided? not available; medline quality followed up with the customer to try and obtain the necessary information, finished good/component trending was performed, and quality control inspections records were reviewed.Investigation results: not confirmed; sample required to determine cause.No trends were identified for the specified material number and its corresponding defect type, and the division will monitor complaints through quarterly trending.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.

• 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: sangameswaran saravanakumar ; three lakes drive; northfield 60093--275
• MDR Report Key: 50691033
• Report Number: 1417592-2026-34662
• Device Sequence Number: 5927796
• Product Code: MPO
• UDI-Device Identifier: 10080196719655
• UDI-Public: 10080196719655
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/04/2026

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: VN25119A10
• Was Device Available for Evaluation?: No
• 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: 01/08/2026
• Initial Report FDA Received Date: 09/09/2026
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 115 LB