BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19048002 · Received April 4, 2024

    Report

    Report Number
    2210968-2024-03913
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    December 21, 2021
    Report Date
    April 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-03914. CITATION: CAN UROL ASSOC J 2022;16(5):E294-7. HTTP://DX.DOI.ORG/10.5489/CUAJ.7561.

    Description of Event or Problem · 0

    TITLE: TECHNIQUES ¿ MINI-INCISION AND PLICATION (MIP) CURE HYDROCELE: A MINIMALLY INVASIVE SURGICAL VARIATION. THE AIM OF THIS RETROSPECTIVE, SINGLE-SURGEON AUDIT IS TO PRESENT THE MINI-INCISION AND PLICATION (MIP) CURE HYDROCELE TECHNIQUE, A MINIMALLY INVASIVE SURGICAL VARIANT FOR THE PRIMARY TREATMENT OF IDIOPATHIC HYDROCELE. A TOTAL OF 92 PATIENTS (ALL MALES; MEAN AGE WAS 55 YEARS) THAT UNDERWENT MIP FOR SYMPTOMATIC HYDROCELE AT THREE HOSPITALS IN SYDNEY, AUSTRALIA, BETWEEN JANUARY 2013 AND DECEMBER 2020, WERE INCLUDED IN THE STUDY. A TIGHT HEMOSTATIC RUNNING 2-0 VICRYL SUTURE ON A TAPERED NEEDLE WAS USED TO PLICATE THE EVERTED FREE EDGES OF THE HYDROCELE POSTERIOR TO THE EPIDIDYMAL TAIL; THE PLICATION WAS CONTINUED PROXIMALLY TO THE SPERMATIC CORD BASE (SNUG BUT NOT TOO TIGHT). THE SCROTUM WAS CLOSED IN LAYERS (3-0 VICRYL ON TAPERED NEEDLE FOR DARTOS AND 4-0 MONOCRYL ON CUTTING NEEDLE TO SKIN). REPORTED COMPLICATIONS INCLUDE TRANSIENT POST-SURGICAL EDEMA (N=20), SMALL HEMATOMA (N=4), HYDROCELE RECURRENCE (N=1), SCROTAL CELLULITIS (N=1), CHRONIC TESTICULAR PAIN (N=1), HYPERESTHESIA (N=2), AND STITCH GRANULOMA (N=1). IN CONCLUSION, THIS MIP TECHNIQUE ACHIEVES EVERSION AND PLICATION WITH MINIMAL HYDROCELE MANIPULATION, PROVIDING EXCELLENT SUCCESS RATES INDEPENDENT OF HYDROCELE SIZE, A RECURRENCE RATE OF <1%, AND FEWER COMPLICATIONS. PROSPECTIVE COMPARATIVE TRIALS COMPARING MIP TO THE POPULAR JABOULAY AND LORD WOULD BE USEFUL TO DETERMINE SUPERIORITY BEFORE MAINSTREAM ADOPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267424 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention