BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHONEY UNKNOWN

    MDR report key: 24647984 · Received March 20, 2026

    Report

    Report Number
    3005920706-2026-00026
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    May 22, 2026
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    FRO
    PMA / PMN Number
    NI
    Removal / Correction Number
    300592070612192025011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 0

    MEDWATCH 5183435. A CUSTOMER REPORTED: "I RECEIVED MY PRODUCT (MEDIHONEY GEL WOUND) ON 2025. I STARTED APPLYING THE PRODUCT ON MY TOE ON 2025, AND ON 2026, MY TOE BECAME INFECTED. I WENT TO MY PRIMARY CARE PHYSICIAN AND PODIATRIST TO LOOK AT THE INFECTION. I WAS PRESCRIBED ANTIBIOTICS. THE INFECTION CONTINUED AND ON 2026 MY TOE WAS AMPUTATED. I WAS HOSPITALIZED A WEEK. I WAS TREATED FOR THE AMPUTATION AND ALSO A BACTERIA IN MY BLOOD. NOW, I AM AT HOME WITH A PORTABLE IV THAT WILL ADMINISTER ANTIBIOTICS FOR 2 WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556287 MEDIHONEY UNKNOWN WOUND RECON - ADVANCED FRO DERMA SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Disability AMLODIPINE.| ATORVASTATIN.| BAYER-LOW DOSE.| EZETIMIBE.| ISOSORBIDE.| JARDIANCE.| LOSARTAN.| METOPROLOL.| OZEMPIC.