BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 22145276 · Received June 4, 2025

    Report

    Report Number
    2210968-2025-06285
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    February 14, 2024
    Report Date
    June 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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: SURG ONCOL. 2024 APR;53:102048. HTTPS://DOI.ORG/10.1016/J.SURONC.2024.102048. EPUB 2024 FEB 14. PMID: 38412756.

    Description of Event or Problem · 0

    TITLE: SCARLESS TOTALLY IMPLANTABLE VENOUS ACCESS PORT (TIVAP) IMPLANTATION: SURGICAL TECHNIQUE, PRELIMINARY RESULTS, LEARNING CURVE, AND PATIENTS-REPORTED OUTCOME IN 125 BREAST CANCER PATIENTS. THE AIM OF THIS STUDY IS TO PROPOSED A NEW SCARLESS TECHNIQUE FOR TIVAP (TOTALLY IMPLANTABLE VENOUS ACCESS PORT) IMPLANTATION, AND REPORTED THE PRELIMINARY RESULTS, LEARNING CURVE, AND PATIENTS-SURVEYED OUTCOME. BETWEEN 1 MAY 2018 TO 31 DECEMBER 2022, A TOTAL OF 125 BREAST CANCER PATIENTS WHO RECEIVED SCARLESS TIVAP PROCEDURES WERE ENROLLED IN THE CURRENT STUDY. THE WOUND WAS CLOSED LAYER BY LAYER INCONSPICUOUSLY INTO THE AXILLA WITH 3-0 ANTI-BACTERIAL COATED VICRYL AND 4-0 MONOCRYL SUTURE. REPORTED COMPLICATIONS ARE: N=1; SEROMA, N=2; KINKING OF THE CATHETER OR MALPOSITION OF THE RESERVOIR PORT (C-D GRADE IIIA), N=2; INFECTION. IN CONCLUSION, THE CURRENT PROPOSED SCARLESS TIVAP IMPLANTATION IS A SAFE AND RELIABLE PROCEDURE WITH HIGH PATIENTS-REPORTED SATISFACTION. THIS TECHNIQUE HOLDS SIGNIFICANT PROMISE AS A FEASIBLE ALTERNATIVE FOR PATIENTS REQUIRING CHEMOTHERAPY WHO DESIRE A LESS NOTICEABLE SCAR LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357789 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention