MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY TUBE - 1.5 FL OZ (44 ML) - STERILE; MEDIHONEY OTHER

Catalog Number	31515
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medihoney was not returned for evaluation: this complaint alleges infection after continued use of medihoney product ordered online at amazon on 4 separate occasions.Since no lot numbers were provided, no dhr review or lot commonality query could be completed.The customer did not have a prescription for the product, which is requirement for the sale of the device.This product was purchased online at amazon by 2 separate sellers.Neither of these sellers or parent businesses are still selling product on amazon.No product was returned for evaluation in this case.It has been confirmed that there are sales of counterfeit medihoney devices being sold on amazon.Fda and integra has taken steps to remove any listings of medihoney devices on amazon.Without return of device for evaluation, we are unable to confirm that the product is a genuine integra device or if it is a counterfeit sold on the online marketplace.There is no evidence to suggest that the product caused the infection to occur, but if the product is returned or the customer responds to the requests for further information, any possible source of contaminants within the product will be investigated and dhr review can be initiated.This complaint is considered unconfirmed at this time.
Event or Problem Description
N/a.
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 an infection while using medihoney (id 31515) for months.The wound worsened and resulted in three surgeries, two of which were due to infections.No additional information has been provided after several attempts.

• Brand Name: MEDIHONEY TUBE - 1.5 FL OZ (44 ML) - STERILE
• Common Device Name: MEDIHONEY OTHER
• 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: 20578398
• Report Number: 3005920706-2024-00011
• Device Sequence Number: 8226846
• Product Code: FRO
• UDI-Device Identifier: 10381780486824
• UDI-Public: 10381780486824
• Combination Product (Y/N): N
• PMA/510(K) Number: K080315
• 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,Followup
• Report Date (Section B): 01/30/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 31515
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 01/13/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/31/2024; 01/30/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 30052920706/09132024/C/0
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male