BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19235717 · Received May 2, 2024

    Report

    Report Number
    2210968-2024-05081
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    January 1, 2023
    Report Date
    May 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. 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. EUROPEAN UROLOGY OPEN SCIENCE 2023;57 (SUPPL 2): S447.

    Description of Event or Problem · 0

    TITLE: SURGICAL APPROACH OF VESICOURETHRAL ANASTOMOSIS STRICTURE AFTER RADICAL PROSTATECTOMY AND FAILED ENDOSCOPIC MANAGEMENT OR OBLITERATIVE BLADDER NECK. THE AIM OF THE STUDY IS TO REVIEW THE CHARACTERISTICS OF THE STRICTURE, THE SURGICAL APPROACH, AND THE TECHNICAL NECESSITY TO RELIEVE ANASTOMOTIC TENSION, MAINLY CAVERNOSAL SEPARATION, PUBECTOMY AND TRANSLOCATION OF THE CORPUS SPONGIOSUM BEHIND THE CAVERNOSUM. WE INCLUDED 7 PATIENTS WITH A MEAN AGE OF 58.6 YEARS. ALL OF THEM HAD A HISTORY OF AT LEAST TWO CERVICOTOMIES AND 3 OF THEM HAD A SUPRAPUBIC CYSTOSTOMY. THERE WAS A HISTORY OF RADIOTHERAPY IN 2 PATIENTS. IN THE DIAGNOSTIC STUDY, RETROGRADE URETHROCYSTOGRAPHY AND COMBINED URETHROCYSTOGRAPHY FOR SUPRAPUBIC CYSTOSTOMY WERE PERFORMED TO ASSESS THE LOCATION OF STRICTURES AND THE DISTANCE BETWEEN URETHRAL ENDS. IT WAS NECESSARY TO SEPARATE THE CORPORA CAVERNOSA IN ALL PATIENTS AND PARTIAL PUBECTOMY TO ACHIEVE A TENSION-FREE ANASTOMOSIS. A SUPRAPUBIC APPROACH WITH ANTEGRADE CATHETERISATION WAS NECESSARY IN 3 PATIENTS TO LOCATE THE PROXIMAL END. THE URETHRAL ANASTOMOSIS WAS PERFORMED WITH LOOSE MONOCRYL (ETHICON) STITCHES. THE REPORTED COMPLICATIONS INCLUDED (N=2) URINARY TRACT INFECTION TREATMENT: NOT MENTIONED, (N=1) HEMATOMA TREATMENT: NOT MENTIONED, (N=3) URINARY INCONTINENCE TREATMENT: NOT MENTIONED, (N=2) FISTULA TREATMENT: SURGERY. IN CONCLUSION, THE COMBINED PERINEAL APPROACH FOR THE MANAGEMENT OF POSTERIOR URETHRAL STRICTURE IS A COMPLEX SURGERY THAT MUST BE PERFORMED IN SPECIALIZED CENTERS. A TENSION-FREE ANASTOMOSIS MUST BE ACHIEVED, AND DIFFERENT METHODS ARE AVAILABLE, MAINLY SEPARATION OF CORPORA CAVERNOSA AND PUBECTOMY. IT IS IMPORTANT TO INFORM THE PATIENT OF THE RISK OF INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999673 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention