BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22171734 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06540
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    April 18, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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: EUROPEAN JOURNAL OF PLASTIC SURGERY (2024) 47:47 DOI: HTTPS://DOI.ORG/10.1007/S00238-024-02193-2.

    Description of Event or Problem · 0

    TITLE: RESTORING FACIAL SUPERFACIAL MUSCULAR APONEUROTIC SYSTEM DEFECTS AFTER PERMANENT FILLERS REMOVAL USING FASCIAL AND SMAS GRAFTS: A PRELIMINARY STUDY. THE AIM OF THIS STUDY IS TO EXAMINED THE INTRAOPERATIVE SUPERFICIAL MUSCULAR APONEUROTIC SYSTEM (SMAS) AND TISSUE ABNORMALITIES ENCOUNTERED DURING FACELIFT AFTER PERMANENT FILLER REMOVAL. THIS CASE DESCRIBES RECONSTRUCTIVE TECHNIQUES USED IN 10 WOMEN WITH SMAS DEFECTS FOLLOWING FACELIFT WITH PERMANENT FILLER EXTRACTION. DEFECTS WERE REPAIRED USING TEMPORALIS FASCIA, AND MASTOID FASCIA, OR COMBINED PLATYSMA-SMAS GRAFTS. THE DURATION OF STUDY WAS BETWEEN OCTOBER 2020 AND DECEMBER 2022. PRE- AND POSTOPERATIVE PHOTOGRAPHS WERE EVALUATED BY TWO INDEPENDENT SURGEONS FOR MIDFACE VOLUME ANALYSIS. PDS 2/0 (ETH) WAS USED TO PERFORMED AND FIXED THE SUPERFICIAL MUSCULAR APONEUROTIC SYSTEM (SMAS), WHILE MONOCRYL 4/0 (ETH) WAS USED TO SECURED THE POSITION OF AVAILABLE GRAFTS. REPORTED COMPLICATIONS: PDS 2/0 (ETH) MONOCRYL 4/0 (ETH) WOMEN (N=10) HEMATOMA (N=1) TREATMENT: DRAINAGE AND COMPRESSION TEMPORARY BUCCAL NERVE WEAKNESS (N=1) TREATMENT: PHYSIOTHERAPY IN CONCLUSION, THIS STUDY SHOWS PROMISING AESTHETIC OUTCOMES AND HIGH PATIENT SATISFACTION AT 6 MONTHS AFTER SIMULTANEOUS FACELIFT AND PERMANENT FILLER REMOVAL WITH VOLUME DEFECT CORRECTION USING VARIOUS LOCAL TISSUE GRAFTS. LARGER STUDIES WITH LONGER FOLLOW-UPS ARE WARRANTED TO FURTHER ASSESS THESE RECONSTRUCTIVE TECHNIQUES FOR SIGNIFICANT SMAS DEFECTS RESULTING FROM IMPROPER PERMANENT FILLER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632489 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention