BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22117288 · Received May 30, 2025

    Report

    Report Number
    2210968-2025-06074
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    December 19, 2024
    Report Date
    May 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: AESTHETIC PLAST SURG. 2024 DEC 19. HTTPS://DOI.ORG/10.1007/S00266-024-04519-8. EPUB AHEAD OF PRINT. PMID: 39702847.

    Description of Event or Problem · 0

    TITLE: NEW CONCEPTS IN CIRCUMAREOLAR MASTOPEXY: THE "STAR INTERLOCKING SUTURE"-A CASE SERIES. THIS STUDY PRESENTS A CASE OF ALL PATIENTS UNDERGOING BREAST SURGERY WITH CIRCUMAREOLAR APPROACH. BETWEEN JANUARY 2019 TO DECEMBER 2021, THE ¿¿STAR INTERLOCKING SUTURE¿¿ WAS PERFORMED IN 19 FEMALE PATIENTS WHILE USING 4¿0 MONOCRYL (ETHICON) AND UPSIDE-DOWN STAR INTERLOCKING SUTURE WAS PLACED USING A 3/0 ETHIBOND. OF THE 19 PATIENTS, 16 UNDERWENT PRIMARY SURGERY, WHEREAS THREE PATIENTS HAD SECONDARY SURGERY FOR BREAST IMPLANT EXCHANGE. REPORTED COMPLICATIONS ARE N=1, THE KNOT WAS TOO SUPERFICIAL AND THUS PALPABLE AND VISIBLE IN CONCLUSION, OUR TECHNIQUE CAN BE CONSIDERED A GOOD COMPROMISE BETWEEN THE CLASSIC BENELLI¿S ¿¿ROUND BLOCK¿¿ AND THE HAMMOND¿S ¿¿INTERLOCKING GORE-TEX SUTURE,¿¿ PROVIDING STABILITY TO THE AREOLAR DIAMETER OVER TIME WHILE ENSURING AT THE SAME TIME SUTURE IMPALPABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36860 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention