MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE

Catalog Number	31815
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A customer reported a medihoney gel (id 31815) caused a leg to become red and hot.She stated that, "it had a burning feeling that hurt really bad.So, i just quit using it.Thought maybe i was allergic to it.".
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The medihoney (id 31815) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A medical assessment was requested to integra's medical affairs team and the following was concluded: localized reactions to medical honey are anticipated, regionally limited skin responses and are documented in the product risk files, including: local reaction (includes pain) skin burning sensation (synonymous with stinging, which may or may not be accompanied by redness or other signs of irritation).A corrective and preventative action (capa) was initiated based off of issues defined by multiple hhes (health hazard evaluation) executed for medihoney product families.Medihoney is pending remediation activities and had been on product hold since 28mar2025 under quarantine.

• Brand Name: MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE
• Common Device Name: MEDIHONEY GEL
• 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 ; 6099362319
• MDR Report Key: 23497131
• Report Number: 3005920706-2025-00023
• Device Sequence Number: 12978651
• Product Code: FRO
• UDI-Device Identifier: 10381780486886
• UDI-Public: 10381780486886
• Combination Product (Y/N): N
• PMA/510(K) Number: K101793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005920706/01102025/R/00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Unknown