BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15029830 · Received July 15, 2022

    Report

    Report Number
    2210968-2022-05552
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    January 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: TRANSPLANT INTERNATIONAL. 2021 AUG; CONFERENCE: 20TH BIENNIAL EUROPEAN SOCIETY FOR ORGAN TRANSPLANTATION CONGRESS, ESOT 2021. MILAN ITALY. 34(SUPPL 1) :294.

    Description of Event or Problem · 0

    TITLE: RETROSPECTIVE AND DESCRIPTIVE STUDY OF INCISIONAL HERNIA PREVALENCE ON KIDNEY TRANSPLANT AND RISK FACTORS ASSOCIATED. THE AIM OF THIS STUDY WAS TO DISCOVER ACTUAL IH PREVALENCE ON PATIENTS WITH KIDNEY TRANSPLANT (KT) AND TO ANALYZE DIFFERENT VARIABLES WHICH COULD INFLUENCE ON ITS APPARITION. RETROSPECTIVE AND DESCRIPTIVE STUDY ON KT PATIENTS IN OUR MEDICAL CENTER BETWEEN 2016 AND 2019 WITH 2 YEARS TRACING. ANALYSIS OF DIFFERENT VARIABLES DESCRIBED ON LITERATURE WHICH COULD BE RELATED TO IH. 130 TRANSPLANT PATIENTS WERE ANALYZED. ALL OF THEM WERE SUBJECTED TO PARARECTAL GIBSON INCISION APPROACH AND SURGICAL CLOSURE WAS MADE WITH VICRYL SUTURE (ETHICON). REPORTED COMPLICATIONS INCLUDED URINARY TRACT INFECTION, SURGICAL SITE INFECTION ,HEMATOMA AND URINARY LEAK. IN CONCLUSION INCISIONAL HERNIA (IH) PREVALENCE REACHED 25.5% AND THEY WERE RELATED TO SURGICAL COMPLICATIONS OCCURRENCE. AS IT HAS BEEN DEMONSTRATED IN MIDLINE LAPAROTOMY, PROPHYLACTIC MESH USE AT SURGICAL CLOSURE COULD BE VALUABLE AND MERITS PROSPECTIVE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423754 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention