BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22320344 · Received June 24, 2025

    Report

    Report Number
    2210968-2025-07323
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 23, 2024
    Report Date
    June 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: J FR OPHTALMOL. 2024 SEP;47(7):104192. HTTPS://DOI.ORG/10.1016/J.JFO.2024.104192. EPUB 2024 MAY 23. PMID: 38788252.

    Description of Event or Problem · 0

    TITLE: FUNCTIONAL OUTCOMES OF CANALICULAR LACERATION REPAIR WITH SELF-RETAINING MASTERKA STENT IN A TERTIARY EYE CARE CENTER IN FRANCE: A RETROSPECTIVE STUDY OF 30 PATIENTS. THE AIM OF THIS STUDY IS TO EVALUATE THE LONG-TERM FUNCTIONAL OUTCOMES OF CANALICULAR LACERATION REPAIR USING THE MASTERKA® MONOCANALICULAR INTUBATION SYSTEM IN 30 PATIENTS WHO UNDERWENT CANALICULAR LACERATION REPAIR WITH A 30-MM PUSHED MONOCANALICULAR STENT (MASTERKA) AND SUTURING OF THE LACERATED CANALICULUS WITH 8/0 VICRYL (ETH) INTERRUPTED SUTURES WHICH WAS USED APPROXIMATED TO THE TWO END OF THE LACERATED CANALICULUS. REPORTED COMPLICATIONS: 8/0 VICRYL (ETH), STENT EXTRUSION (N=2), TREATMENT FOR PATIENT 1: STENT REMOVAL, TREATMENT FOR PATIENT 2: STEROID TREATMENT, PUNCTAL GRANULOMA (N=1), TREATMENT: STEROID TREATMENT, LOWER CANALICULUS (N=23), TREATMENT: TREATMENT: RECONSTRUCTING WITH TEMPORARY STENT, UPPER CANALICULUS (N=7), TREATMENT: RECONSTRUCTING WITH TEMPORARY STENT. IN CONCLUSION, REPAIRING CANALICULAR LACERATIONS USING THE SELF-RETAINING MASTERKA MONOCANALICULAR INTUBATION SYSTEM DEMONSTRATED A NOTABLE ACHIEVEMENT IN LONG-TERM FUNCTIONAL SUCCESS WHILE PRESENTING MINIMAL COMPLICATIONS. TO FURTHER SUBSTANTIATE THESE PROMISING RESULTS, AN INTERVENTIONAL STUDY THAT INCLUDES A COMPARISON ANALYSIS WITH OTHER TYPES OF INTUBATION METHODS IS WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427576 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention