BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22187054 · Received June 11, 2025

    Report

    Report Number
    2210968-2025-06639
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    April 5, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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: INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 14, NO. 4, APRIL 2025; DOI: 10.69605/IJLBPR_14.4.2025.64. HTTPS://IJLBPR.COM/ABSTRACTISSUE.PHP?ID=5665.

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE STUDY ON SUTURAL FIXATION OF NASOGASTRIC TUBE VIA THE MEMBRANOUS NASAL SEPTUM IN FREE FLAP RECONSTRUCTION FOR ORAL CANCERS AT A TERTIARY CARE CENTRE IN MUMBAI. THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY, EFFICACY, AND COMPLICATION PROFILE OF SUTURAL FIXATION OF NASOGASTRIC (NG) TUBES USING THE MEMBRANOUS NASAL SEPTUM IN PATIENTS UNDERGOING MICROSURGICAL FREE FLAP RECONSTRUCTION FOR ORAL SQUAMOUS CELL CARCINOMA (OSCC). BETWEEN JANUARY 2023 AND JUNE 2024, A TOTAL OF 60 CONSECUTIVE PATIENTS WITH BIOPSY-PROVEN OSCC REQUIRING FREE FLAP RECONSTRUCTION WERE ENROLLED IN THE STUDY. THERE WERE 50 MALES AND 10 FEMALES WITH THE MEAN AGE OF PATIENTS WAS 52.6 YEARS; 83.3% WERE MALE. THE SUTURAL FIXATION TECHNIQUE INVOLVED PASSING A 2-0 VICRYL ROUND-BODIED SUTURE THROUGH THE MEMBRANOUS NASAL SEPTUM FROM THE NOSTRIL BEARING THE NG TUBE TO THE CONTRALATERAL NOSTRIL. THE MEAN FOLLOW-UP DURATION WAS NOT REPORTED. REPORTED COMPLICATIONS ARE THE FOLLOWING: 2-0 VICRYL (ETHICON): -8 CASES OF NASOGASTRIC (NG) TUBE DISLODGEMENT WAS OBSERVED TREATMENT: NOT REPORTED - PARTIAL EXPULSION OCCURRED IN 5 PATIENTS (8.3%) TREATMENT: NOT REPORTED -COMPLETE EXPULSION WAS NOTED IN 3 PATIENTS (5%) TREATMENT: NOT REPORTED IN CONCLUSION, THIS PROSPECTIVE CLINICAL STUDY HIGHLIGHTS THE EFFECTIVENESS OF SUTURAL NASOGASTRIC TUBE FIXATION THROUGH THE MEMBRANOUS NASAL SEPTUM AS A SECURE, LOW-COMPLICATION ALTERNATIVE IN PATIENTS UNDERGOING MICROSURGICAL FREE FLAP RECONSTRUCTION FOR ORAL CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96555 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other