MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,HONEY,THERAHONEY,.5 OZ TUBE

Catalog Number	MNK0005
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when foil is removed from tubes large quantity of honey gel squirts from tube without squeezing tube.Wastes product and makes a mess on tube.
Additional Manufacturer Narrative
The customer reported that product ¿pops¿ out of tube without being squeezed and when staff or patients hold in middle of tube even more product leaks.Medline received one sample; this tube appeared to have air pockets which causes the honey to spill over when opening, and the honey did not appear abnormal.The customer reported issue "squirts from tube" was confirmed with the received sample.At this time, root cause appears to be related to filling of tubes during manufacturing; the cause code was updated to reflect cannot determine cause w/received sample, and there has been no change to the reportability decision associated with this complaint.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: DRESSING,HONEY,THERAHONEY,.5 OZ TUBE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854357
• Report Number: 1417592-2026-47500
• Device Sequence Number: 9553930
• Product Code: FRO
• UDI-Device Identifier: 30884389161566
• UDI-Public: 30884389161566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131796
• 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): 09/21/2026

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: MNK0005
• Device Lot Number: LMPTH0241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• 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: 06/12/2024
• Initial Report FDA Received Date: 09/22/2026
• 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