BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUACEL EXTRA 5X5CM

    MDR report key: 5097054 · Received September 23, 2015

    Report

    Report Number
    1000317571-2015-30147
    Event Type
    Death
    Date Received
    September 23, 2015
    Date of Event
    October 14, 2011
    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
    NURSE

    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). EVALUATION CONCLUSIONS ARE REFLECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT HAS DIED! DIAGNOSIS: MULTIPLE TRAUMA, FEMUR FRACTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629211 AQUACEL EXTRA 5X5CM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 420671

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR Death