BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 533908 · Received July 13, 2004

    Report

    Report Number
    2210968-2004-00386
    Event Type
    Injury
    Date Received
    July 13, 2004
    Date of Event
    October 1, 1994
    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 HOSP IN 10/1994 FOR SCHEDULED CORONARY ARTERY BYPASS SURGERY TIMES FOUR THE NEXT DAY. POST-OPERATIVELY PT DEVELOPED DRAINAGE FROM THEIR LEFT THIGH DONOR SITE. INFECTIOUS DISEASES WAS CONSULTED AND CULTURES TAKEN 10/1994 WERE NOTED BY THE PHYSICIAN AS NEGATIVE HOWEVER CULTURE REPORT NOTED THE FINAL ISOLATE 1 GREW RARE DIPTHEROIDS AND THE FINAL ISOLATE 2 GREW RARE STAPHYLOCOCCUS COAGULASE NEGATIVE. PT WAS DISCHARGED IN STABLE CONDITION.

    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 55 YR Required Intervention