BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 287202 · Received July 27, 2000

    Report

    Report Number
    2210968-2000-00283
    Event Type
    Death
    Date Received
    July 27, 2000
    Date of Event
    June 18, 1999
    Report Date
    June 27, 2000
    Manufacturer
    ETHICON, INC. SOMERVILLE
    Product Code
    GAO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT IN 1999 THE PT UNDERWENT A FIVE VESSEL BYPASS PROCEDURE. ETHICON SUTURES WERE USED TO SUTURE THE ARTERIES. IT WAS ALLEGED THAT THE SUTURE OVER THE MAIN ARTERY OF THE PT'S HEART BROKE POSTOPERATIVELY. AS PER THE ATTORNEY, THIS CAUSED BLOOD TO LEAK INTO THE PERICARDIAL SAC. ON JUNE 18, 1999, THE PT AWOKE WITH COMPLAINTS OF PAIN AND WAS TAKEN TO THE HOSP. DUE TO THE AMOUNT OF BLOOD LEAKING INTO THE PERICARDIAL SAC, THE PT WENT INTO A CARDIAC ARREST AND SUBSEQUENTLY DIED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAO ETHICON, INC. SOMERVILLE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death