BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL EXTRA 10X10CM

    MDR report key: 5111740 · Received September 29, 2015

    Report

    Report Number
    1000317571-2015-30039
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    June 20, 2012
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). 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 "DETERIORATION IN WOUND WHEN USING AQUACEL EXTRA AND AQUACEL FOAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642195 AQUACEL EXTRA 10X10CM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 420672

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention