BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 4170470 · Received October 14, 2014

    Report

    Report Number
    2210968-2014-14542
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LITERATURE JOURNAL ARTICLE THAT PATIENTS UNDERWENT ELECTIVE CABG EITHER ALONE OR IN COMBINATION WITH AORTIC VALVE REPLACEMENT OR MITRAL VALVE REPAIR/REPLACEMENT AS PART OF A CLINICAL TRIAL ON UNKNOWN DATES AND SUTURE WAS USED. THE STUDY EXAMINED SURGICAL SITE INFECTION IN LEG-WOUND CLOSURES FOLLOWING OPEN VEIN HARVESTING FOR CORONARY ARTERY BYPASS GRAFTING. FOLLOWING THE PROCEDURE, SOME PATIENTS EXPERIENCED INFECTION AND THE MOST COMMONLY IDENTIFIED MAIN PATHOGENS WERE (B)(6). SOME OF THE PATIENTS RECEIVED ANTIBIOTIC THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651395 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention