BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 709099 · Received May 4, 2006

    Report

    Report Number
    6000089-2006-00870
    Event Type
    Injury
    Date Received
    May 4, 2006
    Date of Event
    March 17, 2006
    Report Date
    April 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    SAME AS REPORT 6000093-2006-00802 AND 6000093-2006-00803. POST A CORONARY DRUG ELUTING STENT PROCEDURE, THE PT DEVELOPED A RASH. THE PT RECEIVED 3 TAXUS EXPRESS2 DRUG ELUTING STENT IMPLANTS IN MARCH 2006. 10 DAYS LATER THE PT DEVELOPED A RASH. HCP IS AWARE OF THE RASH AND IS TREATING IT MEDICALLY WITH AN ANTIHISTAMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0 X 24MM 8163103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other