BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 20652204 · Received November 11, 2024

    Report

    Report Number
    2210968-2024-11766
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    January 13, 2022
    Report Date
    November 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: MIYOSHI N, FUJINO S, NISHIMURA J, SUZUKI Y, UEDA M, UEMURA M, FUJII M, MURATA K, DOKI Y, EGUCHI H; CLINICAL STUDY GROUP OF OSAKA UNIVERSITY, COLORECTAL CANCER TREATMENT GROUP (CSGOCG); AND. EFFECTIVENESS OF TRICLOSAN-COATED SUTURES COMPARED WITH UNCOATED SUTURES IN PREVENTING SURGICAL SITE INFECTION AFTER ABDOMINAL WALL CLOSURE IN OPEN/LAPAROSCOPIC COLORECTAL SURGERY. J AM COLL SURG. 2022 JUN 1;234(6):1147-1159. HTTPS://DOI.ORG/10.1097/XCS.0000000000000167. EPUB 2022 APR 8.

    Description of Event or Problem · 0

    TITLE: EFFECTIVENESS OF TRICLOSAN-COATED SUTURES COMPARED WITH UNCOATED SUTURES IN PREVENTING SURGICAL SITE INFECTION AFTER ABDOMINAL WALL CLOSURE IN OPEN/ LAPAROSCOPIC COLORECTAL SURGERY. THE AIM OF THE STUDY WAS TO SHOW RELIABLE DATA ON THE EFFECTIVENESS OF TRICLOSAN-COATED SUTURES FOR ABDOMINAL FASCIA CLOSURE IN RELATION TO SURGICAL SITE INFECTIONS (SSIS), COMPARED WITH THAT OF UNCOATED SUTURES. BETWEEN JULY 2016 AND JULY 2019 AFTER PROPENSITY SCORE MATCHING, A TOTAL OF 1,579 PATIENTS (864 MALE AND 715 FEMALE) WITH A MEAN AGE OF 68.26 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT ELECTIVE SURGERY FOR COLORECTAL CANCER (CRC), AND WERE DIVIDED INTO 2 GROUPS; THE TRICLOSAN-COATED SUTURES GROUP USING A PDS PLUS;ETHICON AND/OR A VICRYL PLUS SUTURE;ETHICON (N=926); AND THE UNCOATED SUTURES GROUP USING A VICRYL SUTURE;ETHICON (N=653). REPORTED COMPLICATIONS INCLUDE: SURGICAL SITE INFECTIONS FOR THE COATED GROUP (N=39), AND SURGICAL SITE INFECTIONS FOR THE UNCOATED GROUP (N=44). CONCLUSION: OUR PROSPECTIVE STUDY, WHICH FOCUSED ON CRC SURGERIES, SHOWED THE SIGNIFICANT EFFECT OF TRICLOSAN-COATED SUTURES IN PREVENTING SSI. OUR RESULTS ARE SIMILAR TO THOSE OF PREVIOUSLY PUBLISHED RCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890428 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other