BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - STERILE

    MDR report key: 25330483 · Received May 29, 2026

    Report

    Report Number
    3005920706-2026-00037
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    FRO
    PMA / PMN Number
    K101793
    Removal / Correction Number
    300592070612192025011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL HEALTH EFFECT - CLINICAL CODE - E231501.

    Description of Event or Problem · 0

    IT WAS REPORTED A CUSTOMER'S MOTHER WAS USING MEDIHONEY GEL (ID 31805) FOR STANDARD WOUND CARE MANAGEMENT. SHORTLY AFTER APPLICATION, SHE BEGAN DEVELOPING SEVERE SIGNS OF LEG INFECTION, INCLUDING REDNESS, EXTREME PAIN, SWELLING, PUS, AND HOSPITALIZATION, WHICH CAUSED SIGNIFICANT MEDICAL INJURY, PHYSICAL DISTRESS, AND FINANCIAL BURDEN. MEDIHONEY WAS APPLIED BY A HEALTHCARE PROFESSIONAL ON (B)(6) 2025 TO TREAT A SURGICAL WOUND DUE TO AN ANKLE FRACTURE. THE INFECTION STARTED ON (B)(6) 2025, AND THE MEDIHONEY WAS DISCONTINUED ON (B))6) 2025. THE PATIENT'S LEG WOUND HAS HEALED, BUT SHE IS STILL TAKING ANTIFUNGAL MEDICATION. ACCORDING TO INFORMATION PROVIDED, THE PATIENT HAS NO COMORBIDITIES OR HEALTH CONDITIONS THAT AFFECT HEALING. NO CULTURE WAS TAKEN TO IDENTIFY THE TYPE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102687 MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - STERILE WOUND RECON - ADVANCED FRO DERMA SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other