BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM EXTRA THIN DRESSING

    MDR report key: 3993986 · Received July 24, 2014

    Report

    Report Number
    1049092-2014-00335
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAD
    PMA / PMN Number
    K891696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF COMPLAINT IS AS FOLLOWS: "THE BROKEN POUCH SEALING OF THE STERILE PACKAGE WAS NOTED BEFORE USE. WE FOUND THIS COMPLAINT SAMPLE IN OUR OWN WAREHOUSE. PRODUCT CONTENTS DAMAGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435167 DUODERM EXTRA THIN DRESSING OCLUSIVE WOUND DRESSINGS NAD CONVATEC, INC. 187957 2E02331

    Patients

    Seq Age Sex Outcome Treatment
    1