BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 22283243 · Received June 18, 2025

    Report

    Report Number
    2210968-2025-07030
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    April 23, 2024
    Report Date
    June 18, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: CLIN EXP MED. 2024 APR 23;24(1):82. HTTPS://DOI.ORG/10.1007/S10238-024-01344-W. PMID: 38653874; PMCID: PMC11039536.

    Description of Event or Problem · 0

    TITLE: IMPROVING QUALITY OF LIFE AFTER BREAST CANCER: A COMPARISON OF TWO MICROSURGICAL TREATMENT OPTIONS FOR BREAST CANCER-RELATED LYMPHEDEMA (BCRL). THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO COMPARE SAFETY AND EFFECTIVENESS OF VLNT AND LVA IN PATIENTS WITH CHRONIC BREAST CANCER RELATED LYMPHEDEMA (BCRL). BETWEEN JAN 1ST, 2015, AND DEC 31ST, 2022, A TOTAL OF 105 PATIENTS WERE INCLUDED IN THE STUDY. CONSISTS OF 100 FEMALE AND 5 WERE MALE. AMONG THESE, 58 PATIENTS UNDERWENT VLNT SURGERY WITH THE MEAN AGES OF 54.0 PLUS OR MINUS 9.8 YEARS, WHILE 47 PATIENTS HAD LVA SURGERY AND THE MEAN AGES OF 53.7 PLUS OR MINUS 11.3 YEARS. IN VLNT TREATED WITH 9-0 OR 10-0 ETHILON STITCHES AND 3-0 VICRYL SUTURE. FOLLOW-UP PERIOD OF TWO YEARS. REPORTED COMPLICATIONS: SEROMA-N=5, TREATMENT: NEEDLE ASPIRATION, HEMATOMA-N=1, TREATMENT: NEEDLE ASPIRATION/EVACUATION. IN CONCLUSIONS, BOTH VLNT AND LVA OFFER SIGNIFICANT IMPROVEMENT FOR PATIENTS SUFFERING FROM CHRONIC BCRL. VLNT SHOWS AN EVEN GREATER POTENTIAL FOR IMPROVEMENT IN MORE SEVERE CASES OF BCRL BUT INVOLVES A HIGHER RISK FOR (MOSTLY MINOR) COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854147 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention