BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24364018 · Received February 17, 2026

    Report

    Report Number
    2210968-2026-01665
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    November 16, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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: J STOMATOL ORAL MAXILLOFAC SURG. 2025 NOV 16;127(2):102658. HTTPS://DOI.ORG/10.1016/J.JORMAS.2025.102658 EPUB AHEAD OF PRINT. PMID: 41253229.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: MULTIVECTOR GRACILIS MUSCLE TRANSFER FOR SMILE REANIMATION IN LONG-STANDING FACIAL PARALYSIS: SIMULTANEOUS UPPER AND LOWER LIP CONSTRUCTION. THIS STUDY EVALUATED A MULTIVECTOR GRACILIS TRANSFER DESIGNED TO SIMULTANEOUSLY REANIMATE BOTH THE UPPER AND LOWER LIPS. BETWEEN 2020 AND 2024, A TOTAL OF 29 PATIENTS WITH LONG-STANDING UNILATERAL FACIAL PARALYSIS WHO UNDERWENT MULTIVECTOR GRACILIS FREE MUSCLE TRANSFER. THE GRACILIS WAS TAILORED INTO A FORKED CONFIGURATION, WITH SLIPS ANCHORED TO THE ORAL COMMISSURE, UPPER LIP, AND LOWER LIP. THE MUSCLE CROSS-SECTION WAS CLOSED USING CONTINUOUS LOCKING ABSORBABLE SUTURES (4-0 VICRYL) TO MINIMIZE BLEEDING AND REINFORCE LONGITUDINAL TENSION. THE MEAN FOLLOW-UP WAS 1.76 PLUS OR MINUS 0.95 YEARS. REPORTED COMPLICATIONS: 4-0 VICRYL (ETHICON): (N=1) PATIENT (3.4 %) EXPERIENCED A HEMATOMA ON THE SECOND POSTOPERATIVE DAY. TREATMENT: NOT REPORTED (N=3) CASES (10.3 %) OF A SECONDARY DEBULKING PROCEDURE WAS PERFORMED TO ADDRESS FLAP BULKINESS. TREATMENT: REQUIRING SECONDARY DEBULKING . IN CONCLUSIONS, THIS MULTIVECTOR FORKED GRACILIS DESIGN ENABLES ONE-STAGE REANIMATION OF BOTH THE UPPER AND LOWER LIPS, IMPROVING FUNCTIONAL AND AESTHETIC OUTCOMES IN DYNAMIC SMILE RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149526 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention