BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALE FOAM DRESSING

    MDR report key: 5955823 · Received September 14, 2016

    Report

    Report Number
    MW5064798
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    CELLERA, LLC
    Product Code
    NAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS CLAIMED AS "STERILE" BUT VENDOR COULD NOT PROVIDE USP STERILITY TESTING REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601587 VITALE FOAM DRESSING FOAM DRESSING NAD CELLERA, LLC
    601588 VITALE FOAM DRESSING FOAM DRESSING NAD CELLERA, LLC
    601589 VITALE FOAM DRESSING FOAM DRESSING NAD CELLERA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1