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
Event or Problem Description
A customer reported a wound got infected around the time he was using medihoney (id 31515).No additional information was provided after several attempts.
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.
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 root cause(s) of the reported issue could not be determined.The complaint indicates that the customer purchased medihoney sku 31515 on amazon and received a recall notice for the product.Customer reports that they had an infection of their wound around the time of use of the product.The recall is for the optional applicator tip due to packaging sterility concerns.The customer has not confirmed if the applicator tip was used in this case or not.If the customer used the applicator tip, it is possible that there was a breach of sterility of the applicator packaging which could lead to infection.It is also possible that in the normal course of healing and treatment of the wound that the wound became infected by outside sources (other products, lack of protection of the wound, contamination of the wound site from environmental sources, lack of following instruction for use of the product).Without further information provided by the customer of evaluation of a returned product, further narrowing of possible sources of infection cannot be made.The customer has not provided the lot number, any photos of the product or wound for examination, and has not responded to any gfe communication requests for further information.As a result, no dhr review or lot commonality query could be initiated.The report of infection could not be confirmed.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 a 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.This investigation may be closed at this time but may be reexamined if the customer provides any additional information.
Event or Problem Description
N/a.

• 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: 20635964
• Report Number: 3005920706-2024-00014
• Device Sequence Number: 7422868
• Product Code: FRO
• UDI-Device Identifier: 10381780486824
• UDI-Public: 10381780486824
• 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,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: 10/20/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 06/02/2025
• Initial Report FDA Received Date: 11/07/2024
• 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: Required Intervention
• Patient Sex: Unknown