BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    MDR report key: 4171037 · Received October 14, 2014

    Report

    Report Number
    2210968-2014-14561
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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    IT WAS REPORTED IN AN UNPUBLISHED MANUSCRIPT THAT PATIENTS UNDERWENT CABG EITHER ALONE OR IN COMBINATION WITH VALVE SURGERY AS PART OF A DOUBLE-BLIND RANDOMIZED TRIAL ON UNKNOWN DATES AND SUTURE WAS USED. THE STUDY EXAMINED STERNAL WOUND SURGICAL SITE INFECTION FOLLOWING STERNOTOMY. FOLLOWING THE PROCEDURE, SOME PATIENTS EXPERIENCED INFECTION, MOST WERE SUPERFICIAL AND SOME WERE DEEP. THE MOST COMMONLY IDENTIFIED MAIN PATHOGENS WERE (B)(6) 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
    650761 MONOCRYL POLIGLECAPRONE 25 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention