BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVER-SEPT SILVER ANTIMICROBIAL SKIN AND WOUND GEL

    MDR report key: 11700460 · Received April 20, 2021

    Report

    Report Number
    MW5100883
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    April 16, 2021
    Manufacturer
    ANACAPA TECHNOLOGIES, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MY CONCERN IS ABOUT LABELING. THIS PRODUCT IS A MEDICINE, APPARENTLY CONSIDERED A MEDICAL DEVICE, BUT IT IS AN ANTIMICROBIAL OINTMENT USED ON SERIOUS WOUNDS. THEREFORE, THIS PRODUCT IS ABSORBED INTO THE BODY. THE PROBLEM IS, THEY APPARENTLY ARE NOT REQUIRED TO LIST THEIR INGREDIENTS, OTHER THAN THE SILVER AND THE PURIFIED WATER. AND THEY WOULD NOT TELL ME WHAT THE OTHER INGREDIENTS ARE, AS THEY ARE A "TRADE SECRET". PRODUCTS LIKE THIS SHOULD NOT BE ALLOWED KEEP INGREDIENTS SECRET. WHAT IS CONSIDERED SAFE NOW, MAY NOT BE CONSIDERED SAFE IN THE FUTURE. WHAT IS SAFE FOR SOME PATIENTS, MAY NOT BE SAFE FOR OTHERS. SO FULL DISCLOSURE OF INGREDIENTS SHOULD BE REQUIRED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590705 SILVER-SEPT SILVER ANTIMICROBIAL SKIN AND WOUND GEL DRESSING, WOUND, DRUG FRO ANACAPA TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1