MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,HONEY,THERAHONEY,1.5 OZ TUBE

Catalog Number	MNK0015
Medical Device Problem Codes	Burst Container or Vessel (1074); Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 tubes of item mnk0015 manuka honey have crystalized and hardened.
Additional Manufacturer Narrative
The customer reported issue of product being crystallized and hardened with item mnk0015 dressing,honey,therahoney,1.5 oz tube.Medline reviewed the sample returned and was able to confirm an issue with a peanut butter color and the tubes bursting.The issue was confirmed with the samples.Cause was documented as mfg: machine/automation process error under dc: supplier error non-asia(medline brnd); the supplier was notified, the qa team and the division are working to assess appropriate corrective actions with the vendor, and the division will continue to monitor trending through the quarterly trend reports.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,1.5 OZ TUBE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50888735
• Report Number: 1417592-2026-50414
• Device Sequence Number: 10679842
• Product Code: FRO
• UDI-Device Identifier: 40884389154558
• UDI-Public: 40884389154558
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/24/2026

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: MNK0015
• Device Lot Number: LMPTH0214B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2023
• 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: 04/21/2023
• Initial Report FDA Received Date: 09/24/2026
• 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