BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUACEL AG

    MDR report key: 5095195 · Received September 22, 2015

    Report

    Report Number
    1000317571-2015-30124
    Event Type
    Death
    Date Received
    September 22, 2015
    Date of Event
    December 7, 2010
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K063271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION (B)(4) AND (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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 IT WAS RECEIVED INFORMATION ABOUT THE DEATH OF PATIENT. MEDICAL DOCUMENTATION IS NOT AVAILABLE. SUBJECT WAS RANDOMIZED TO AQUACEL AG/AQUACEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626279 AQUACEL AG DRESSING, WOUND, DRUG FRO CONVATEC LIMITED AQUACEL AG - CLINICAL TRIAL PRODUCT - WOUND CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death