BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRRAGEN ADVANCED WOUND MATRIX

    MDR report key: 18149786 · Received November 15, 2023

    Report

    Report Number
    MW5148179
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ETS WOUND CARE LLC.
    Product Code
    QSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM BEING TREATED FOR SLOW HEALING WOUND , A COMBINATION ARTERIAL AND VENOUS ULCER. I HAD BEEN USING PICO 7 WOUND VAC WHICH HAD REDUCED THE SIZE OF THE WOUND AND I HAD NO PAIN. ON (B)(6) 2023 DURING MY 10:00 AM APPOINTMENT, A NEW TREATMENT WAS ADDED. IT WAS MIRRRAGEN ETS, A "RESORBABLE BORATE GLASS WOUND MANAGEMENT DEVICE". ABOUT 2:00 PM I STARTED TO HAVE PAIN IN THE WOUND AND IT INCREASED INTO THE EVENING AND OVERNIGHT. I CALLED THE DOCTOR'S OFFICE AND STOPPED USING. AT MY NEXT WEEKLY APPOINTMENT, THE WOUND WAS LARGER AND DEEPER AND DOCTOR REMARKED ABOUT THE LOOK OF THE WOUND. I HAVE NOT BEEN WITHOUT PAIN SINCE THAT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912663 MIRRAGEN ADVANCED WOUND MATRIX ABSORBABLE SYNTHETIC WOUND DRESSING QSZ ETS WOUND CARE LLC. 0404180-1

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention| O CEQUA FOR DRY EYES.| FOLIC ACID AND ONE BABY ASPIRIN.| METHOTREXATE.| MULTIVITAMINS.