BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBALT CHROMIUM

    MDR report key: 1080860 · Received July 1, 2008

    Report

    Report Number
    MW5007763
    Event Type
    Other
    Date Received
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP - MAPLE GROVE/POST MARKET COMPLIANCE
    Product Code
    MAF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP BECAME AWARE OF A REPORTABLE EVENT THAT WAS REPORTED AS INVOLVING 6-605 COBALT CHROMIUM (COCR) ALLOY STENT; HOWEVER, BOSTON SCIENTIFIC DOES NOT MFR 6-605 COBALT CHROMIUM (COCR) ALLOY STENT. AS REPORTED: IN 2007, MY HUSBAND HAD AN ANGIOPLASTY PERFORMED. THREE DAYS LATER, HE HAD A STENT IMPLANT. IT IS A STENT WITH 6-605 COBALT CHROMIUM (COCR) ALLOY. ACCORDING TO THE PATIENT'S GUIDE TO STENT IMPLANTATION BOOKLET IT STATES "PERSONS ALLERGIC TO L-605 COBALT CHROMIUM (COCR) ALLOW MAY SUFFER AN ALLERGIC REACTION TO THIS IMPLANT." THE PREVIOUS DAY, HE DEVELOPED AN ITCH AND RASH OF SOME SORT OVER HIS BODY. AFTER COMPLAINING OF THE ITCH HOSPITAL PERSONEL GAVE HIM AN OINTMENT FOR THE ITCH. HOWEVER, AFTER 3 MONTHS OF COMPLAINING TO DOCTORS, THEY SENT HIM TO A DERMATOLOGIST WHO HAS PRESCRIBED SEVEN (7) DIFFERENT PRESCRIPTIONS FOR ITCH. IT APPEARS NO DR IS CONSIDERING THE STENT OR LISTENING TO BE IN REGARDS TO THE STENT. THE DOCTORS KEEP TELLING US THAT IT IS FROM A MEDICATION CALLED PLAVIX WHICH UNFORTUNATELY THEY STOPPED 3 MONTHS LATER AND THE PROBLEM STILL EXISTS. I WOULD APPRECIATE IF YOU COULD TELL ME WHAT IS 6-605 COBALT CHROMIUM (COCR) ALLOY IS AS THAT MAY BE THE CAUSE OF THE ITCH AND RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT CHROMIUM NONE MAF BOSTON SCIENTIFIC CORP - MAPLE GROVE/POST MARKET COMPLIANCE 6-605

    Patients

    Seq Age Sex Outcome Treatment
    1