MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,SHEET,HD,THERAHONEY,2X2

Catalog Number	MNK0082
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in each piece of all the packages the honey drips from the dressings, generating distrust that the component is working.".
Additional Manufacturer Narrative
This is a combination product the customer reported honey drips from the dressings and that customers reject this product under these conditions.Medline reviewed the received photos, notified the supplier of the issue for all reported lots, and reviewed trending for this item.The customer reported issue "leaking" was confirmed with the received photos for one lot; additional lots were reported but not confirmed.As of now, this is believed to be an overfilling issue at the supplier's manufacturing site, and the division will continue to monitor trending through the quarterly trend reports; this complaint is ok to close.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,SHEET,HD,THERAHONEY,2X2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50873342
• Report Number: 1417592-2026-49447
• Device Sequence Number: 10690715
• Product Code: FRO
• UDI-Device Identifier: 30884389947535
• UDI-Public: 30884389947535
• Combination Product (Y/N): Y
• Initial Reporter Country: PM
• PMA/510(K) Number: K120976
• 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): 09/23/2026

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: MNK0082
• Device Lot Number: W02305835
• 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: 12/29/2023
• Initial Report FDA Received Date: 09/23/2026
• 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