BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX

    MDR report key: 2847067 · Received November 15, 2012

    Report

    Report Number
    MW5027706
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2011
    Report Date
    November 15, 2012
    Manufacturer
    ULURU INC, APLUS SECURE PACKAGING
    Product Code
    NAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT, ALTRAZEAL TRANSFORMING DRESSING MARKETED BY ULURU, INC. (B)(4), AND PRODUCED BY A+ SECURE PACKAGING AS (B)(4). I BELIEVE THE PRODUCT IS NOT MARKETED UNDER THE CORRECT DESIGNATION. FURTHER, THE PRODUCT APPEARS TO DISSOCIATE AFTER APPLICATION AND FORM SMALL PARTICLES. THE COMPANY SCIENTIST INSISTS THAT THE PRODUCT DOES NOT FALL APART, HOWEVER A TEST OF THE POWDER WHICH TRANSFORMS FROM A POWDER INTO AN INTACT FILM, IN SALINE AT OUR OFFICE SHOWS THAT TINY PARTICLES DO FLOAT FREE FROM THE MATERIAL. FURTHER, THE PRODUCT IS DESCRIBED AS A NANOFLEX TECHNOLOGY BY THE COMPANY AND PACKAGING. WHEN ASKED ABOUT THE MATERIAL, THE SALES REP INDICATED THAT THE PRODUCT WAS DEVELOPED WITH NANOTECHNOLOGY BUT AFTER FORMATION DID NOT HAVE ANY NANOPARTICLES SPECIFICALLY IN IT. REQUESTS FOR TESTING SHOWED SOME MICROSCOPE IMAGES BUT THE COMPANY DID NOT INDICATE THAT THEY HAD A DIALOGUE WITH THE FDA ON THE PRODUCT, ONLY THAT IT MET ALL SAFETY REQUIREMENTS. THE COMPANY WAS UNAWARE ON THE DRAFT GUIDANCE OF CONSIDERING WHETHER THE FDA-REGULATED PRODUCT INVOLVED THE APPLICATION OF NANOTECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX ALTRAZEAL 5GM NAE ULURU INC, APLUS SECURE PACKAGING

    Patients

    Seq Age Sex Outcome Treatment
    1