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)
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 patient reported an infection when started using medihoney (id 31515).Therefore, she stopped using the product and the infection was gone.No additional information has been provided after several attempts.
Additional Manufacturer Narrative
Updated h9.
Additional Manufacturer Narrative
The medihoney (id: 31515) 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 customer indicated that an injury became infected after use of the product.No lot number was provided, no photos were provided of the product or wound, no product was returned and no response from the customer was given to any gfe communications.Due to the lack of information, dhr review and lot commonality trending could not be performed.The customer indicates that the product was ordered on amazon.The seller is no longer operating on amazon.Federal law requires that the product be sold and used only under the supervision of a physician per the ifu.As the product was used outside of indications for use, this complaint may be categorized as a user error.There are no legal sales of any medihoney products on amazon and integra has confirmed that amazon is selling counterfeit products under the product name of medihoney.Integra initiated corrective and preventative action (capa), as medihoney products are indicated as rx only devices; however, they are being sold ¿over the counter¿ through online retailers.There are currently no controls to prevent this distribution.The reported infection cannot be confirmed with the information provided by the customer.This investigation may be closed at this time but may be reexamined if the customer provides any additional information.
Event or Problem Description
Na.

• 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: 20578379
• Report Number: 3005920706-2024-00013
• Device Sequence Number: 15454504
• 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): 06/18/2025

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: 10/15/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 06/02/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/31/2024; 06/18/2025
• 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: Other
• Patient Sex: Unknown