MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - STERILE; WOUND RECON - ADVANCED

Catalog Number	31805
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported: "i was issued a tube of medihoney from k.Urgent care when i had a knee wound that needed the application.I kept the tube, figuring it hadn¿t expired.I got a cut on my hand and tried to use the product, and it was brown instead of yellow.I realized the cap of the tube keeps turning, as though the tube itself is separated from the nozzle.The expiration date is 2026-07-01." additional information: what was the date of the first application to your knee wound? "5 mar 2025" was the medihoney only used for one time? "it was used until the wound closed.I found out it was a broken tube when i decided to try and use it on a wound i got on my hand recently.The gel is a dark brown (not yellow, like it was originally)." did a healthcare professional apply the product, or did you apply it yourself at home? "the first time, they applied it at urgent care, but they told me how to apply it at home.".
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - STERILE
• Common Device Name: WOUND RECON - ADVANCED
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer (Section G): DERMA SCIENCES, INC.; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 25638168
• Report Number: 3005920706-2026-00042
• Device Sequence Number: 9680083
• Product Code: FRO
• UDI-Device Identifier: 10381780486978
• UDI-Public: 10381780486978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/30/2024
• Device Catalogue Number: 31805
• Device Lot Number: 2432
• Was Device Available for Evaluation?: No
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 08/28/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown