BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURNSHIELD

    MDR report key: 274390 · Received April 6, 2000

    Report

    Report Number
    MW4002742
    Event Type
    Malfunction
    Date Received
    April 6, 2000
    Report Date
    April 6, 2000
    Manufacturer
    LEVTRADE INT'L (PTY) LTD.
    Product Code
    MGQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/3/00: 1. "NON-IRRITANT" - CO HAS CONDUCTED INDEPENDENT MEDICAL STUDIES WHICH PROVE PRODUCT IS NON-IRRITANT. 2. "ACTIVE INGREDIENT BEING MELALEUCA ALTERNIFOLIA" - THERE IS NOTHING MISLEADING ABOUT THIS STATEMENT. PRODUCT CONTAINS THIS INGREDIENT WHICH IS KNOWN TO HAVE MANY BENEFITS. 3. "BURNSHIELD CAN BE USED AS AN EMERGENCY CARE FOR SUPERFICIAL TO FULL THICKNESS BURNS" - AGAIN CO HAS MEDICAL TRIALS AND MANY CASE REPORTS TO SUPPORT THIS STATEMENT. 4. "ABLE TO INHIBIT INFECTION" - MEDICAL TRIALS CONDUCTED BY CO AS WELL AS MANY OTHER RESEARCHERS WORLDWIDE HAVE PROVEN CERTAIN INGREDIENTS ACT AS INHIBITORS TO MICROBIOLOGICAL GROWTH THUS INHIBITING INFECTIONS UPON TREATMENT WITH PRODUCT. 5. "DOES NOT INDUCE HYPOTHERMIA" - MANY CASE STUDIES SUPPORT THIS CLAIM. CO IS OF THE OPINION THAT IT DOES NOT MAKE ANY MISLEADING STATEMENTS. STATEMENTS REGARDING THE PRODUCT ARE MADE BASED ON PROVEN FACTS. THE REASON WHY THE "OTHER" SIMILAR PRODUCTS MENTIONED IN THE REPORT DO NOT MAKE THE SAME CLAIMS IS THAT CO WAS THE ORIGINAL MFR OF THIS PRODUCT AND HAS MANY YEARS EXPERIENCE AND VALUABLE INFO REGARDING PRODUCT WHICH OBVIOUSLY ITS COMPETITORS DO NOT HAVE.

    Description of Event or Problem · 1

    A CO CALLED LEVTRADE, WHICH MARKETS A FIRST AID PRODUCT FOR BURN INJURIES CALLED "BURNSHIELD" HAS MADE SOME CLAIMS ON THEIR INTERNET PAGE WHICH RPTR THINKS MAY BE MISLEADING TO MEDICAL PROFESSIONALS AND END USERS. RPTR FAMILIAR WITH OTHER VERY SIMILAR PRODUCTS WHICH RPTR KNOWS DON'T MAKE SUCH CLAIMS. THEY CLAIM ON THEIR WEBSITE THAT THEY ARE "FDA APPROVED". RPTR DID LOOK UP THEIR 510-K SUBMISSION, AND THEY HAVE RECEIVED PERMISSION TO MARKET. HOWEVER, THEY MAKE OTHER CLAIMS ON THEIR WEBSITE THAT RPTR BELIEVES ARE NOT APPROPRIATE AND ARE MISLEADING. YOU MAY VIEW THIS WEBSITE AT: HTTP://WWW.BURNSHIELD.COM. THE STATEMENTS RPTR BELIEVES ARE MISLEADING ARE: "NON-IRRITANT", "ACTIVE INGREDIENT BEING MELALEUCA ALTERNIFOLIA", "BURNSHIELD CAN BE USED AS AN EMERGENCY CARE FOR SUPERFICIAL TO FULL THICKNESS BURNS", "ABLE TO INHIBIT INFECTIONS", "DOES NOT INDUCE HYPOTHERMIA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURNSHIELD EMERGENCY CARE OF BURNS MGQ LEVTRADE INT'L (PTY) LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *