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

Catalog Number	MNK0005
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported issue ¿doesn¿t stay on patient, different consistency¿ with dressing,honey,therahoney,.5 oz tube; the complaint transcript also states ¿different consistency than others¿ and ¿used.¿ the received sample ¿appeared to be within specification and nothing abnormal was observed regarding the consistency,¿ and trending was reviewed for the item.The reported issue could not be confirmed with the received sample, and the cause was documented as ¿preference/item to spec¿ / ¿this complaint may be due to customer preference.¿ the division will continue to monitor trending through the quarterly trend reports, and ¿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.
Event or Problem Description
It was reported that the dressing ¿doesn¿t stay on patient, different consistency than others.¿.

• 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: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691842
• Report Number: 1417592-2026-34762
• Device Sequence Number: 15866664
• Product Code: FRO
• UDI-Device Identifier: 30884389161566
• UDI-Public: 30884389161566
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/04/2026

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: MNK0005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2023
• 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: 10/20/2023
• Initial Report FDA Received Date: 09/09/2026
• 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