BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE-MOISTURE RETENTIVE

    MDR report key: 3802016 · Received February 12, 2014

    Report

    Report Number
    1049092-2014-00052
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 17, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAD
    PMA / PMN Number
    K891696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE PRODUCT WAS REPORTED A SNOT BEING USED BY THE COMPLAINT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING COMPLAINT WAS REPORTED BY THE HOSPITAL BUYER: GREEN COLOR FOREIGN MATTER IN THE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92886 DUODERM/GRANUFLEX/DUOACTIVE-MOISTURE RETENTIVE OCCLUSIVE WOUND DRESSINGS NAD CONVATEC INC. 187957 3B01760

    Patients

    Seq Age Sex Outcome Treatment
    1