BEUDAMED
    FDA Adverse Event Death Summary report: N

    3003768277-2008-00023

    MDR report key: 1132386 · Received August 20, 2008

    Report

    Report Number
    3003768277-2008-00023
    Event Type
    Death
    Date Received
    August 20, 2008
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. ALSO, THE SITE IS REFUSING AT THIS TIME TO RELEASE THE MUSHROOM SWITCH FOR THE MFR'S ANALYSIS. THE INVESTIGAITON IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. NOTE THE INDICATED IMPORTER HAS RECEIVED FDA EXEMPTION NUMBER TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER AND MFR FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IZI

    Patients

    Seq Age Sex Outcome Treatment
    1