BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18799019 · Received February 28, 2024

    Report

    Report Number
    2210968-2024-02088
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    November 15, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. RELATED EVENTS CAPTURED VIA 2210968-2024-02089 AND 2210968-2024-02090. CITATION: HTTPS://DOI.ORG/10.1016/J.BJPS.2023.11.011.

    Description of Event or Problem · 0

    TITLE: ASSESSMENT OF DEEP PLANE FACELIFT COMBINED WITH FASCIA LATA GRAFT FOR THE STATIC TREATMENT OF FACIAL PALSY: A PRELIMINARY REPORT. THE AIM OF THIS STUDY IS TO DESCRIBE AND TO ASSESS A NEW STATIC TECHNIQUE COMBINING DEEP PLANE FACELIFT AND FASCIA LATA GRAFT FOR FACIAL PALSY (FP) TREATMENT. WE CONDUCTED A PROSPECTIVE PILOT STUDY ENROLLING UNILATERAL FP PATIENTS AGED > 55 AND DECLINING FREE FUNCTIONAL MUSCLE TRANSFERS (FFMT). THE AUTHORS CONDUCTED A PROSPECTIVE PILOT STUDY BETWEEN DECEMBER 2017 AND MARCH 2022 ON PATIENTS WITH UNILATERAL FP. A TOTAL OF 15 PATIENTS UNDERWENT THE PROCEDURE WITH AN AVERAGE AGE OF 57-75 YEARS DURING THE SURGERY. THE UPPER SLIP OF THE FASCIA LATA GRAFT (FLG) INTENDED FOR INSERTION WAS TUNNELED TO THE MIDLINE OF THE UPPER LIP. IT WAS PASSED AROUND THE ORBICULARIS ORIS MUSCLE, AKIN TO A PULLEY MECHANISM AND WAS SECURED USING THE 4-0 CLEAR PROLENE SUTURE (ETHICON); SUPERFICIAL MUSCULOAPONEUROTIC SYSTEM (SMAS) WAS ANCHORED TO THE PREAURICULAR FASCIA USING PDS II 2-0 SUTURE (ETHICON) AND THE EXCESS CUTANEOUS TISSUE WAS EXCISED USING PDS 4-0 AND VICRYL RAPID 5-0 (ETHICON). REPORTED COMPLICATIONS IS WOUND DEHISCENCE. IN CONCLUSION, ALL PATIENTS INDICATED THAT THE PROCEDURE HAD SIGNIFICANTLY ENHANCED THEIR OVERALL QUALITY OF LIFE, SURPASSING THEIR PREOPERATIVE EXPECTATIONS. PATIENT RESPONSES CONVEYED A HEIGHTENED SENSE OF OPTIMISM, REDUCED EMBARRASSMENT, INCREASED SELF-ASSURANCE, AND IMPROVED COMFORT IN SOCIAL INTERACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224139 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other