BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 24590567 · Received March 13, 2026

    Report

    Report Number
    2210968-2026-02577
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    November 23, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ANN CHIR PLAST ESTHET. 2026 JAN;71(1):33-40. DOI: 10.1016/J.ANPLAS.2025.11.007. EPUB 2025 DEC 29. PMID: 41469279. HTTPS://DOI.ORG/10.1016/J.ANPLAS.2025.11.007

    Description of Event or Problem · 0

    IMMEDIATE MICROSURGICAL BREAST RECONSTRUCTION FOLLOWING VERTICAL INCISION MASTECTOMY IN PATIENTS WITH PTOTIC BREASTS: AN INTERNATIONAL MULTICENTER CASE SERIES. THE AIM OF THIS STUDY IS TO DESCRIBE THIS SURGICAL APPROACH AND EVALUATE ITS OUTCOMES. BETWEEN JANUARY 2019 AND MARCH 2023, A TOTAL OF 35 PATIENTS UNDERWENT SKIN-SPARING MASTECTOMY FOLLOWED BY IMMEDIATE AUTOLOGOUS BREAST RECONSTRUCTION USING ETHILON 9¿0 SUTURES, VICRYL 2¿0, AND MONOCRYL 3¿0. REPORTED COMPLICATIONS ARE N=1; FREE FLAP FAILURE. TREATMENT: NOT MENTIONED. N=1; WOUND DEHISCENCE. TREATMENT: NOT MENTIONED. IN CONCLUSION, THE VERTICAL SKIN RESECTION TECHNIQUE IN SKIN-SPARING MASTECTOMY IMPROVES AESTHETIC OUTCOMES FOR PATIENTS NEEDING RESHAPING OF THE BREAST ENVELOPE. THIS APPROACH PRESERVES VASCULAR INTEGRITY AND PROVIDES EASY ACCESS TO THE AXILLARY AREA, WITHOUT COMPROMISING ONCOLOGICAL SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660338 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other