BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19049606 · Received April 5, 2024

    Report

    Report Number
    2210968-2024-03932
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    November 9, 2022
    Report Date
    April 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED ( VICRYL SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: SURGICAL SITE INFECTION, 59-YEAR-OLD WOMAN- INCISIONAL HERNIA , DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS ( VICRYL SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : NEPHRO-UROL MON.14(4):E130908:1-4. HTTPS://DOI.ORG/10.5812/NUMONTHLY-130908. NOTE: EVENTS REPORTED ON MW# 2210968-2024-03931. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE : FASCIA REPAIR WITH VICRYL SUTURE IN UROLOGIC SURGERIES. THE AIM OF THIS STUDY WAS TO USE THE PROCEDURE FOR FINISHING THE FASCIA SHOULD BE QUICK, EASY, AND PERSISTENT BUT COMFORTABLE FOR THE PATIENT WITH MINIMUM COMPLICATIONS AT THE SURGERY SITE, SUCH AS INFECTION AND HERNIA OR FORMIDABLE FASCIA DEHISCENCE. FROM JANUARY 2018 TO JANUARY 2020, THE FASCIA WAS CONTINUOUSLY SUTURED WITH SIZE 0 OR 1 OF VICRYL IN A DOUBLE LAYER FOR ALL PATIENTS (N=642) IN THE UROLOGY DEPARTMENT. THE FASCIA OF ALL PATIENTS WAS TREATED WITH THE VICRYL SUTURE WITH THE SIZE OF 0 OR 1 IN A DOUBLE LAYER AND A CONTINUOUS MANNER. THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=1) AND HERNIA AT THE FLANK INCISIONAL SITE (N=1). IN CONCLUSION, THE FASCIA REPAIR COULD BE TREATED WITH VICRYL SUTURE IN A CONTINUOUS FORM IN ALL UROLOGIC SURGERIES, WITH A VERY LOW RATE OF WOUND INFECTION AND HERNIA AT THE OPERATION SITE, SINUS FORMATION, AND LONG-TERM SURGICAL SITE DISCOMFORT. HOWEVER, WE SUGGEST MORE RESEARCH TO CONFIRM THE VICRYL SUTURE SAFETY IN UROLOGIC FASCIA REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335292 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention