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

Catalog Number	31805
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/22/2024
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 tube (id 31805) became dark brown after a week of usage and "wound open up and became ugly".The medihoney was prescribed by his foot doctor, and he visited his doctor weekly for a period of a month.The product was kept in a cool place in his room.The product was prepared by cleaning it after a shower, applying it with a q-tip, and covering it with a non-stick small gauge.Currently, the wound is much smaller and still draining a bit, and he was prescribed with another cream, collagenase santillana ointment.
Additional Manufacturer Narrative
Updated fields.The medihoney (b)(4) was not returned for evaluation; however, photos were provided.Dhr - no anomalies were found.Failure analysis/root cause - this complaint alleges that the medihoney discolored and also the wound it was treating "open up and became ugly".The complaint communications, ils investigation, trend analysis, and risk management review were reviewed in developing this failure analysis.The product was purchased otc online at walmart.Com.Federal law restricts this device to sale by or on the order of a physician.Currently, a corrective and preventative action (capa) has been opened to remove medihoney from otc sales on online retailers as this kind of sale is inappropriate.Integra is unable to confirm whether the devices were handled appropriately or per storage requirements.A review from medical affairs shared the following: "ultimately, he reports the wound is smaller but continues to drain.He reports the doctor prescribed the chemical debriding agent ¿ santyl.Mh supports autolytic debridement by the patient¿s own body.Mh is not a chemical debriding agent.Apparently, the patient¿s wound requires a stronger debriding agent.This care pathway will likely result in more drainage from the wound." the customer indicated the wound opened; however, a debriding agent's purpose is to open the wound, implying no failure mode.As for the discoloration, improper storage conditions could lead to product discoloring.However, examining the photos indicates there is no discoloration.Customer reported that product was stored "in a cool place" in their room.Upon examining the customer complaint, no mode of failure could be indicated based on the customer's response.Medihoney is not a debriding agent, however the customer used a debriding agent possibly in conjunction with medihoney with the purpose of debriding the wound.This implies no failure.The customer's implication that medihoney was discolored was not supported by examination of the photos provided.Medihoney is a natural product and the color is a normal color for the product, implying no failure.However, the customer did purchase a prescription product otc, which is under the scope of a current capa.Otherwise, the device appears to be within specifications.The device was not returned, however, if it is returned, testing can be done to confirm device is within specifications.
Event or Problem Description
N/a.

• Brand Name: MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - 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: 21231539
• Report Number: 3005920706-2025-00001
• Device Sequence Number: 8603324
• Product Code: FRO
• UDI-Device Identifier: 10381780486978
• UDI-Public: (01)10381780486978
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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): 03/21/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31805
• Device Lot Number: 2351
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White