MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,SHEET,HD,THERAHONEY,4X5

Catalog Number	MNK0087
Medical Device Problem Codes	Melted (1385); Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "nurse noticed liquid pooling out on the sides of the therahoney sheet.Opened up sheet and found that honey had been melted off sheet.".
Additional Manufacturer Narrative
The customer reported concern of melting therahoney hd sheets and that liquid was pooling out on the sides of the therahoney sheet.The received sample was evaluated, the supplier was notified of the issue, and trending was reviewed for this item.The customer reported issue "liquid pooling out of sides" was confirmed with the received sample.It appears that the dressing was either overfilled or melted, or a combination of both; root cause may be attributed to production at the supplier as they may have overfilled this lot of dressings, and no adverse trending was identified.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,4X5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896628
• Report Number: 1417592-2026-50737
• Device Sequence Number: 13438325
• Product Code: FRO
• UDI-Device Identifier: 30884389823228
• UDI-Public: 30884389823228
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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): 09/24/2026

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: MNK0087
• Device Lot Number: W02301351
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2023
• 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: 11/14/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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