BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 22203420 · Received June 13, 2025

    Report

    Report Number
    2210968-2025-06865
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    January 8, 2024
    Report Date
    June 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: IN VIVO. 2024 MAR-APR;38(2):842-848. HTTPS://DOI.ORG/10.21873/INVIVO.13509. PMID: 38418124; PMCID: PMC10905481.

    Description of Event or Problem · 0

    TITLE: POSTOPERATIVE SCAR MANAGEMENT USING LASER THERAPY FOR BREAST RECONSTRUCTION WITH LATISSIMUS DORSI FLAP. THE AIM OF THIS STUDY IS TO ANALYZED THE RELATIONSHIP BETWEEN VARIOUS FACTORS IN 27 PATIENTS WHO RECEIVED BREAST RECONSTRUCTION USING LATISSIMUS DORSI (LD) FLAP TO INVESTIGATE APPROPRIATE AND EFFECTIVE MANAGEMENT APPROACHES. TWENTY SEVEN PATIENTS WHO UNDERWENT BREAST RECONSTRUCTION BETWEEN JUNE 2014 AND JANUARY 2015 RECEIVED LASER THERAPY ON THEIR LD DONOR SITE AT THE KYUNGPOOK NATIONAL UNIVERSITY CHILGOK HOSPITAL. VICRYL (2-0, 4-0, 5-0; ETH) WERE USED TO CLOSE THE ENDS OF THE DONOR SITE WITH 1.5-CM SPACING, IT WAS ALSO USED FOR THE TOP HALF OF THE DERMIS AND SUBCUTANEOUS FAT LAYER, ALIGNING THEM AS ACCURATELY AS POSSIBLE. WHILE 5-0 ETHILON (ETH) WAS USED TO CLOSED LAYER-BY-LAYER. REPORTED COMPLICATIONS: VICRYL (2-0, 4-0, 5-0; ETH), 5-0 ETHILON (ETH), SEROMA (N=7), TREATMENT: NOT REPORTED, HEMATOMA (N=1), TREATMENT: NOT REPORTED, NECROTIC CHANGE (N=4), TREATMENT: NOT REPORTED. IN CONCLUSION, THE RESULTS OF THE STUDY OBJECTIVELY CONFIRM THAT LASER THERAPY HELPED IMPROVE POSTOPERATIVE SCARRING AND IDENTIFIED STATISTICALLY ASSOCIATED PARAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342118 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other