BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 22568425 · Received July 22, 2025

    Report

    Report Number
    2210968-2025-08462
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    March 24, 2024
    Report Date
    July 22, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: TECHNOL HEALTH CARE. 2024;32(5):3037-3046. DOI: 10.3233/THC-231467. PMID: 38968063. HTTPS://DOI.ORG/10.3233/THC-231467.

    Description of Event or Problem · 0

    POSTOPERATIVE RECOVERY AFTER SUSPENSION SUTURE PLACEMENT AT THE SITE OF ESOPHAGOJEJUNAL ANASTOMOSIS AFTER TOTAL GASTRECTOMY: COMPARISON OF TWO SURGICAL TECHNIQUES. THE AIM OF THIS STUDY IS TO DEMONSTRATE THE ROLE OF ADDITIONAL SUSPENSION SUTURES ON THE ESOPHAGOJEJUNAL ANASTOMOSIS (EJA) TO STRENGTHEN THE ANASTOMOSIS, RELIEVE THE MECHANICAL SUTURE. THIS STUDY WAS CONDUCTED FROM 2011 TO 2022 AT THE CLINIC FOR SURGERY, UNIVERSITY CLINICAL CENTER TUZLA, BOSNIA AND HERZEGOVINA WITH A 212 PATIENTS WERE INCLUDED IN THE STUDY: 87 IN THE EXPERIMENTAL GROUP WITH SUSPENSION SUTURES ON THE EJA AND 125 IN THE CONTROL GROUP WITHOUT SUSPENSION SUTURES ON THE EJA. PDS 3-0 (ETH) AND VICRYL PLUS 3-0 (ETH) WERE USED TRANSVERSELY ON THE ESOPHAGUS AND TRANSVERSELY ON THE SMALL INTESTINE. REPORTED COMPLICATIONS: PDS 3-0 (ETH), VICRYL PLUS 3-0 (ETH), EXPERIMENTAL GROUP (N=87). PLEURAL EFFUSION (N=25) TREATMENT: NOT REPORTED. PNEUMONIA (N=20) TREATMENT: NOT REPORTED. INTRAABDOMINAL ABSCESS (N=13) TREATMENT: NOT REPORTED. SURGICAL SITE INFECTION (N=12) TREATMENT: NOT REPORTED. ACUTE RESPIRATORY DISTRESS SYNDROME (N=2) TREATMENT: NOT REPORTED. PAIN (N=27) TREATMENT: NOT REPORTED. VOMITING (N=8) TREATMENT: NOT REPORTED. HEARTBURN (N=9) TREATMENT: NOT REPORTED. IN CONCLUSION, THE R STUDY DID NOT SHOW A STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO ANALYZED EJA TECHNIQUES CREATED WITH A CIRCULAR STAPLER, WHEN IT COMES TO POSTOPERATIVE COURSE AND OUTCOME IN PATIENTS WITH GASTRIC CANCER. FUTURE PROSPECTIVE AND MULTICENTER STUDIES ARE NECESSARY TO PROVE WHICH OPERATIVE METHODS ARE BEST FOR OPTIMAL OUTCOME AND TREATMENT OF PATIENTS WITH GASTRIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294030 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention