BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM CGF DRS 10X10CM

    MDR report key: 5098066 · Received September 23, 2015

    Report

    Report Number
    1049092-2015-30173
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    September 26, 2012
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED "THAT DUODERM CGF MELTED AND BROKE INTO PIECES ON 2ND DAY DESPITE THE WOUND HAS REEPITHELIALISED AND NOT EXUDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629580 DUODERM CGF DRS 10X10CM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC INC. 187660 1M 01274 S/B 1M01274

    Patients

    Seq Age Sex Outcome Treatment
    1