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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
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 the medihoney is crystalized and is uncomfortable to apply to the affected area (face).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The medihoney (id (b)(4) was not returned for evaluation, but a photo was provided: failure analysis - crystallization is not visible in the provided photo, the complaint is unable to be confirmed.However, thickness of honey is related to the storage temperature.If the honey thickens or crystallizes, body heat would cause the consistency to return to a thinner, more comfortable consistency with no issues.This is normal and not cause for any concern.Retain sample inspection revealed no nc or deviations, and no crystallization was observed in the retained samples.Device history record (dhr) - no non-conformances (nc) or deviations were identified that could have contributed to the reported crystallization issue.Root cause analysis - while this complaint cannot be confirmed, allowing of the product to warm on the skin has been known to melt any crystallization caused by temperature fluctuations.There is no suggestion of non-sterility or risk of infection or non-healing to the patient in using crystallized paste.This complaint may be closed at this time with no further investigation.

• 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: 20368835
• Report Number: 3005920706-2024-00009
• Device Sequence Number: 14389100
• 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
• Report Date (Section B): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 31515
• Device Lot Number: 2315
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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
• Patient Sex: Unknown