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 an infection after medihoney (id 31515) use for an open wound.No additional information has been 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
This complaint indicates that the customer purchased medihoney sku 31515 on amazon and received a recall notice for the product.The customer reported infection with no specific detail, no photos, and no response to gfes.The recall is for the optional applicator tip due to packaging sterility concerns.The customer did not provide any detail regarding if the applicator tip was used.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 report of infection could not be confirmed with the information provided.As no lot number was provided, a lot commonality search could not be performed.Federal law requires that the product be sold and used only under the supervision of a physician per the ifu.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: 21031168
• Report Number: 3005920706-2024-00018
• Device Sequence Number: 9132880
• Product Code: FRO
• UDI-Device Identifier: 10381780486824
• UDI-Public: 10381780486824
• 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,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: 12/09/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 06/02/2025
• Initial Report FDA Received Date: 12/27/2024
• 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