BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 533918 · Received July 13, 2004

    Report

    Report Number
    2210968-2004-00383
    Event Type
    Injury
    Date Received
    July 13, 2004
    Date of Event
    October 2, 1996
    Report Date
    June 16, 2004
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO HOSPITAL WITH CHEST PAIN AND VENTRICULAR TACHYCARDIA. ENZYMES WERE NEGATIVE FOR MYOCARDIAL INFARCTION. IN 09/1996 PT UNDERWENT CARDIAC CATHETERIZATION AND THEN CORONARY ARTERY BYPASS TIMES FOUR FOUR DAYS LATER. PT POSTOPERATIVE COURSE WAS UNEVENTFUL. FOUR DAYS LATER IT WAS NOTED THAT THERE WAS A SMALL AMOUNT OF SEROSANGUINOUS DRAINAGE FROM LEFT THIGH AND PERICARDITIS, WHICH WAS TREATED WITH STEROIDS. PT WAS DISCHARGED 6 DAYS LATER IN STABLE CONDITION TO HAVE A FOLLOW-UP CHEST X-RAY IN FOUR WEEKS. IT WAS NOTED THAT ON DISCHARGE DATE THE INCISION WAS CLEAN AND DRY. THE PT WAS READMITTED TEN DAYS LATER WITH PURULENT DRAINAGE FROM THEIR STERNUM AND 5 CM OF NECROSIS. PT UNDERWENT IRRIGATION AND DEBRIDEMENT OF THE STERNUM THE NEXT DAY AND STERNAL DEBRIDEMENT WITH MUSCLE FLAP REPAIR 5 DAYS LATER. PT WAS DISCHARGED ON HOME IV ANTIBIOTICS SIX DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention