BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6190416

    MDR report key: 6190416 · Received December 13, 2016

    Report

    Report Number
    6190416
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 12, 2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A CT ANGIOGRAM AND DEVELOPED INCREASED SHORTNESS OF BREATH. IMAGE SHOWED AIR IN THE HEART AND VESSELS NEAR THE HEART AFTER CONTRAST INJECTED. THE PT'S CONDITION WAS GUARDED PRIOR TO THE PROCEDURE AND HER SYMPTOMS WORSENED FOLLOWING THE CT AND ANGIOGRAPHY. SHE WAS TRANSFERRED EMERGENTLY FROM THE EMERGENCY DEPARTMENT AT THIS HOSPITAL TO A (B)(6) HOSPITAL FOR FURTHER TREATMENT OF HER CONDITION AND POSSIBLE HYPERBARIC THERAPY. WE HAVE BEEN IN CONTACT WITH THE MFR STARTING WITH THE MORNING OF (B)(6) 2016. THE REP INSTRUCTED THAT THIS REPORT BE FILED WITH THE FDA AND THEY EXPECTED TO RECEIVE A COPY FROM THE FDA. THE REP INFORMED THIS REPORTER THAT THEY WILL FILE A REPORT WITHIN THE TIME PERIOD FOR REPORTING. OUR UNDERSTANDING IS THAT THE PT WAS DISCHARGED FROM THE (B)(6) HOSPITAL ON (B)(6) 2016.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R