BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 4132813 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11336
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    January 28, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    NAD
    PMA / PMN Number
    K881050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NARRATIVE HAS BEEN REVIEWED AND NO ISSUES OTHER THAN THE ADVERSE EVENT ISSUE REPORTED WERE NOTED. FURTHER INVESTIGATION WILL BE CONDUCTED BASED ON THE INFORMATION IN THE CASE.

    Description of Event or Problem · 1

    PER THE END USER, LARGE AMOUNT OF PAIN UNDER DRESSING, ESPECIALLY WHILE WALKING. DRESSING ONLY APPLIED TO LEFT LOWER LEG WOUND. CHANGED DRESSING AFTER 1 DAY DUE TO BLOODY DRAINAGE FROM WOUND. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606958 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING OCCLUSIVE WOUND DRESSINGS NAD CONVATEC INC. 187660 2F01486

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other