BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPISTAXIS CATHETER

    MDR report key: 4332492 · Received December 1, 2014

    Report

    Report Number
    2183502-2014-00913
    Event Type
    Death
    Date Received
    December 1, 2014
    Report Date
    November 26, 2014
    Manufacturer
    SMITHS MEDICAL INC.
    Product Code
    EMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL. THIS INFO WAS ENTERED INTO THE MFRS COMPLAINT DATABASE FOR TRACKING AND REPORTING PURPOSES.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THAT THE DEVICE WAS IN USE WITH PT (GENERAL CONDITION AND HEALTH OF THE PT WAS DESCRIBED AS POOR) FOR 12 HOURS WHEN CUFF DEFLATION WAS OBSERVED. IT WAS REPORTED THAT THE PT SUFFERED HEMORRHAGIC SHOCK AND PASSED AWAY. IT IS UNK AT THIS TIME IF THE DEFLATED CUFF IS CORRELATED TO THE DEATH OF THE PT. FURTHER INFO HAS BEEN REQUESTED. NO FURTHER INFO HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774416 EPISTAXIS CATHETER EMX SMITHS MEDICAL INC. NA 2575018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death