BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHONEY NON-ADHESIVE HCS SHEET, 4.3" X 4.3"

    MDR report key: 23096470 · Received September 19, 2025

    Report

    Report Number
    3005920706-2025-00020
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    April 11, 2025
    Report Date
    November 21, 2025
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    FRO
    PMA / PMN Number
    K110546
    Removal / Correction Number
    3005920706/08052025/R/00
    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.

    Additional Manufacturer Narrative · 0

    THE MEDIHONEY (ID 31644) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) 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. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS RELEVANT TO THIS CASE AS IT INCLUDES ALL MEDIHONEY DEVICES WITHIN THE SCOPE. HEALTH HAZARD EVALUATION (HHE) INCLUDES SKU 31644 WITHIN THE SCOPE. NO HISTORY OF FAILURES OF SKU 31644 WAS IDENTIFIED WITHIN THE HHE HOWEVER SKU 31612 BREACHES OF STERILE BARRIER WERE IDENTIFIED, WHICH RESULTED IN A FIELD ACTION FOR ALL PRODUCTS MANUFACTURED BY INTEGRA (GENTELL FIRST WATER), INCLUDING 31644. THE PUBLIC FIELD ACTION RECALL WAS INITIATED FOR PACKAGING FAILURES WERE IDENTIFIED WHICH COULD LEAD TO A BREACH IN THE STERILE BARRIER. THE HHE INDICATES THAT WHILE ANY LEAK OF THE DEVICE MAY BE APPARENT TO THE USER UPON VISUAL INSPECTION, THE FAILURES FOUND IN SKU 31612 WERE SMALL AND NOT EASILY DETECTED. A MEDICAL ASSESSMENT WAS REQUESTED TO OUR MEDICAL AFFAIRS TEAM AND THE FOLLOWING WAS PROVIDED: "BASED ON THE INFORMATION RECEIVED TO DATE, THERE IS NO CONFIRMED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE INFECTION THAT LED TO AMPUTATION. GIVEN THE CONTINUED CARE OF A HEALTHCARE TEAM PERFORMING DEBRIDEMENT AND APPLICATION, IF THERE HAD BEEN AN ISSUE WITH THE STERILITY OF MEDIHONEY OR A BREACH IN PACKAGING PRIOR TO APPLICATION THAT CAUSED LEAKAGE OR CONTAMINATION, THE HEALTHCARE PROVIDER (HCP) WOULD LIKELY NOT HAVE USED OR APPLIED IT TO THE PATIENT. TO OUR KNOWLEDGE, THE PATIENT¿S CARE TEAM IS NOT INVOLVED IN THIS ALLEGATION. A REQUEST WAS MADE TO THE PATIENT¿S FAMILY MEMBER TO PROVIDE PHYSICIAN AND/OR TREATING FACILITY CONTACT INFORMATION TO OBTAIN CLINICAL AND MEDICAL DETAILS (E.G., MEDICAL RECORDS, OPERATIVE NOTES, PROGRESS NOTES, LAB RESULTS, RELEVANT MEDICAL HISTORY, MEDICATIONS, ETC.) TO VERIFY THE COMPLAINT. TO DATE, NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. INTEGRA MEDIHONEY PASTE, GEL, AND DRESSING PRODUCTS (THE SAME HONEY APPLIED TO ALL DRESSINGS) UNDERWENT COMPREHENSIVE ANTIMICROBIAL CHALLENGE TESTING TO EVALUATE PRESERVATION EFFICACY OVER A DEFINED OPEN SHELF-LIFE PERIOD. THE PRODUCTS WERE INOCULATED WITH HIGH CONCENTRATIONS OF REPRESENTATIVE MICROORGANISMS, INCLUDING ESCHERICHIA COLI, STAPHYLOCOCCUS AUREUS, PSEUDOMONAS AERUGINOSA, CANDIDA ALBICANS, ASPERGILLUS BRASILIENSE'S, AND MIXED POPULATIONS OF YEASTS AND MOLDS. TESTING WAS CONDUCTED AT MULTIPLE TIME POINTS (0, 28 DAYS, 2 MONTHS, AND 4 MONTHS) OVER A 4-MONTH SHELF-LIFE PERIOD. AT EACH TIME POINT, VIABLE MICROORGANISM COUNTS WERE ASSESSED POST-INOCULATION IN ACCORDANCE WITH NAMSA PROTOCOL (B)(6). THE STUDY FOLLOWED USP <51> ANTIMICROBIAL EFFECTIVENESS TESTING AND EUROPEAN PHARMACOPOEIA (EP) 5.1.3 STANDARDS, WHICH EVALUATE THE EFFICACY OF ANTIMICROBIAL PRESERVATIVES AND ASSESS POTENTIAL RISKS ASSOCIATED WITH SINGLE PATIENT MULTIPLE USE (SPMU), INCLUDING CROSS-CONTAMINATION." "MEDIHONEY WILL MAINTAIN A PROPER ENVIRONMENT CONDUCIVE TO WOUND HEALING DUE TO THE MULTIPLE INTRINSIC CHARACTERISTICS FROM THE ALH HONEY COMPONENTS THAT INHIBIT BACTERIAL GROWTH ARE PRINCIPALLY DUE TO THE OVERSATURATION OF SUGARS THAT CAUSES OSMOTIC STRESS, AND THE LOW PH. SEVERAL OTHER COMPOUNDS PRESENT IN MINOR PROPORTIONS ALSO HAVE BEEN IDENTIFIED TO BE RELATED TO THE PROPERTIES OF HONEY SUCH AS HYDROGEN PEROXIDE, PHENOLITIC ACIDS AND FLAVONOIDS, BEE DEFENSIN-1 PEPTIDE, AND METHYLGLYOXAL (MGO) A 1,2-DICARBONYLS-BREAKDOWN-PRODUCT OF ANTIMICROBIAL SIGNIFICANCE AND HAS BEEN IDENTIFIED AS THE MAIN ANTIBACTERIAL COMPOUND IN MANUKA HONEY. THE HIGH LEVELS OF MGO FOUND IN THIS VARIETY OF HONEY ARE FORMED BY THE SPONTANEOUS DEHYDRATION OF DIHYDROXYACETONE, WHICH IS PRESENT AT UNUSUALLY HIGH CONCENTRATIONS IN THE NECTAR OF LEPTOSPERMUM GENUS, INCLUDING LEPTOSPERMUM SCOPARIUM, LEPTOSPERMUM POLYGALIFOLIUM, AND SOME RELATED LEPTOSPERMUM SPECIES NATIVE TO NEW ZEALAND AND AUSTRALIA".

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A MEDIHONEY (ID 31644) WAS USED FOR HIS HUSBAND AND IT WAS NO LONGER STERILE, AND AFTER IT WAS APPLIED, THE WOUND BECAME SEVERELY INFECTED. THE INFECTION PROGRESSED SO BADLY THAT THEY ULTIMATELY HAD TO AMPUTATE HIS LEG. NO ADDITIONAL INFORMATION WAS RECEIVED AFTER SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956656 MEDIHONEY NON-ADHESIVE HCS SHEET, 4.3" X 4.3" MEDIHONEY SHEETS FRO DERMA SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other