BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 4170521 · Received October 14, 2014

    Report

    Report Number
    2210968-2014-14543
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 STAPHYLOCOCCUS AUREUS AND COAGULASE-NEGATIVE STAPHYLOCOCCI. SOME OF THE PATIENTS RECEIVED ANTIBIOTIC THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651648 MONOCRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention