BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUACEL EXTRA 5X5CM

    MDR report key: 5113261 · Received September 30, 2015

    Report

    Report Number
    1000317571-2015-30299
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    February 14, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). EVALUATION CONCLUSIONS ARE REFLECTED IN THE CODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DIED IN HOSPITAL DUE TO PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644033 AQUACEL EXTRA 5X5CM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 420671

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death