BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22297674 · Received June 20, 2025

    Report

    Report Number
    2210968-2025-07141
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    January 22, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: TRANSL ANDROL UROL. 2025 JAN 31;14(1):47-59. HTTPS://DOI.ORG/10.21037/TAU-24-530 EPUB 2025 JAN 22. PMID: 39974805; PMCID: PMC11833543.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE OUTCOMES OF INTERNAL, EXTERNAL, AND NO STENT IN URETEROILEAL ANASTOMOSIS FOR ILEAL ORTHOTOPIC NEOBLADDER RECONSTRUCTION. THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY OF INTERNAL STENT, EXTERNAL STENT, AND NO-STENT TREATMENTS FOR URETEROILEAL ANASTOMOSIS IN LAPAROSCOPIC RADICAL CYSTECTOMY (LRC) COMBINED WITH ILEAL ORTHOTOPIC NEOBLADDER (IONB). THE GOAL WAS TO COMPARE POSTOPERATIVE OUTCOMES AND COMPLICATIONS TO IDENTIFY THE OPTIMAL STENT CHOICE. BETWEEN APRIL 2013 AND DECEMBER 2023. PATIENTS WERE DIVIDED INTO THREE GROUPS: INTERNAL STENT (GROUP A), EXTERNAL STENT (GROUP B), AND NO STENT (GROUP C). A TOTAL OF 51 PATIENTS (42 MALES, 9 FEMALES; MEDIAN AGE: 62 YEARS), INTERNAL STENTS WERE USED IN 18 (35.3%, GROUP A), EXTERNAL STENTS IN 20 (39.2%, GROUP B), AND NO STENTS IN 13 (25.5%, GROUP C) PATIENTS. A 26 CM, 4.5 F STENT WAS PLACED IN THE URETER, AND FIXED TO THE URETERAL STUMP USING 5-0 VICRYL SUTURES (ETHICON). REPORTED COMPLICATIONS ARE: 5-0 VICRYL SUTURES (ETHICON) - MINOR COMPLICATIONS, (CLAVIEN-DINDO GRADE I¿II) (N=21) TREATMENT: NOT REPORTED. -MAJOR COMPLICATIONS, (CLAVIEN-DINDO GRADE III¿V) (N=5) TREATMENT: NOT REPORTED. -FEBRILE URINARY TRACT INFECTION (N= (31.4%) TREATMENT: NOT REPORTED. -RENAL INSUFFICIENCY (N=25.5%) TREATMENT: NOT REPORTED. -HYDRONEPHROSIS (N=23) TREATMENT: NOT REPORTED. -NEOBLADDER URETHRAL ANASTOMOTIC STRICTURE (N=5) TREATMENT: NOT REPORTED. -URETEROILEAL ANASTOMOTIC STRICTURE (UIAS) (PATIENTS) [GROUP B (N=5); GROUP C (N=4)] TREATMENT: GROUP C: 2 OF WHOM REQUIRED TREATMENT: 1 UNDERWENT SURGERY DUE TO BLADDER LEAKAGE AND STENOSIS 6 MONTHS AFTER SURGERY, WITH GOOD RESULTS, WHILE THE OTHER HAD HYDRONEPHROSIS AND INCREASED CREATININE LEVELS, REQUIRING STENT PLACEMENT. TREATMENT FOR THIS PATIENT WAS STOPPED 5 MONTHS AFTER SURGERY DUE TO TUMOR RECURRENCE. THE REMAINING 2 PATIENTS HAD NO RENAL IMPAIRMENT AND DID NOT RECEIVE TREATMENT. IN CONCLUSION, INTERNAL STENTS REDUCE EARLY POSTOPERATIVE COMPLICATIONS, INCLUDING HYDRONEPHROSIS AND RENAL DYSFUNCTION, WHILE LOWERING THE RISK OF LATE UIAS. INTERNAL STENT USE IS A SAFE AND EFFECTIVE OPTION THAT PROMOTES FASTER RECOVERY AND BETTER POSTOPERATIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805987 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention