BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSIVA® XC, NON-ADHESIVE DRESSING, 20CM X 20CM

    MDR report key: 5114084 · Received September 30, 2015

    Report

    Report Number
    1000317571-2015-30294
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    July 19, 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. 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 THE PATIENT DIED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643937 VERSIVA® XC, NON-ADHESIVE DRESSING, 20CM X 20CM DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LIMITED 410614 9J46746

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death