MAUDE Adverse Event Report: DERMA SCIENCES, INC. MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE

Catalog Number	31815
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch mw5166202.A customer reported that the induction seal of a medihoney gel tube was not sealed to tube.No additional information is available.
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 fields: d4, d9, g3, g6, h2, h3, h6, h11.The medihoney gel (id 31815) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The following have been initiated related to this issue: a non-conformance record (nc) with a health hazard evaluation (hhe), a supplier corrective action request (scar) and a corrective and preventative action (capa).

• Brand Name: MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP - STERILE
• Common Device Name: MEDIHONEY GEL
• 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: 21664335
• Report Number: 3005920706-2025-00010
• Device Sequence Number: 7614964
• Product Code: FRO
• UDI-Device Identifier: 30381780486880
• UDI-Public: (01)30381780486880
• 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
• Report Date (Section B): 05/20/2025

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: Lay User/Patient
• Device Expiration Date: 06/01/2025
• Device Catalogue Number: 31815
• Device Lot Number: 2328
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/20/2025
• 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: 3005920706/01102025/R/00
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White