BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 12303573 · Received August 10, 2021

    Report

    Report Number
    2210968-2021-07190
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    April 3, 2020
    Report Date
    August 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. ATTEMPTS ARE BEING MADE TO CLARIFY 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? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WAS TREATMENT PROVIDED FOR THE PRO-LONGED PAIN? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ACTA OBSTET GYNECOL SCAND. 2020;99:1238¿1245. DOI: 10.1111/AOGS.13844. RELATED EVENTS CAPTURED VIA 2210968-2021-07191. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 ¿G/M.

    Description of Event or Problem · 1

    TITLE: EVALUATION OF QUALITY OF LIFE, BODY IMAGE AND SURGICAL OUTCOMES OF ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY AND SENTINEL LYMPH NODE MAPPING IN LOW-RISK ENDOMETRIAL CANCER PATIENTS ¿ A ROBOTIC GYNE CLUB STUDY. THIS STUDY AIMS TO EVALUATE THE FEASIBILITY AND SAFETY OF ROBOTIC SINGLE-SITE (RSS) SURGERY FOR THE STAGING OF EARLY EC BY ANALYZING RSS AND ROBOTIC MULTIPORT (RM) IN TERMS OF SURGICAL OUTCOMES, COSMETIC RESULTS AND QUALITY OF LIFE (QOL). BETWEEN JANUARY 2017 AND JANUARY 2019, 51 CONSECUTIVE PATIENTS WITH GRADE 1-2 EC WITH MYOMETRIAL INVASION < 50% OR ATYPICAL ENDOMETRIAL HYPERPLASIA (AEH) SCHEDULED FOR ROBOTIC HYSTERECTOMY AND SLN MAPPING IN THREE INSTITUTIONS: (B)(6) HOSPITALS WERE ENROLLED IN THE STUDY. TWO GROUPS WERE IDENTIFIED: WOMEN UNDERGOING SURGERY WITH RM (N=51) AGE 61.9 (11.4 YEARS) AND THOSE UNDERGOING SURGERY WITH RSS (N=25) AGE 61.4 (10.4 YEARS) USING THE DA VINCI SI PLATFORM. THE DA VINCI® SI SYSTEM (INTUITIVE SURGICAL) WAS USED TO PERFORM EXTRAFASCIAL TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND SLN MAPPING. BOTH RM AND RSS PLATFORMS WERE USED. THE UTERUS WAS EXTRACTED FROM THE ABDOMINAL CAVITY THROUGH THE VAGINA. VAGINAL CUFF CLOSURE WAS PERFORMED INTERNALLY WITH A SNAKED SINGLE-PORT ROBOTIC NEEDLE-HOLDER AND V-LOC 0/0 BARBED SUTURE (COVIDIEN). THE UMBILICAL INCISION WAS SUTURED IN PLANES WITH NUMBER 1 VICRYL (JOHNSON & JOHNSON INTERNATIONAL) ON THE APONEUROSIS, AND MONOCRYL 3-0 (JOHNSON & JOHNSON INTERNATIONAL) UNDER THE SKIN. CLINICAL FOLLOW-UP WAS PERFORMED AT 4 WEEKS AND 6 AND 12 MONTHS AFTER SURGERY. REPORTED COMPLICATIONS INCLUDED: INCREASED PAIN SYMPTOMS (INCISION SITE) AT 6 AND 12 MEAN MONTHS AFTER RSS SURGERY (N=?). PAIN SYMPTOMS (INCISION SITE) AT 6 AND 12 MONTHS AFTER RM SURGERY (N=?). IT WAS CONCLUDED, THAT ROBOTIC MULTIPORT AND RSS ARE BOTH PRACTICABLE APPROACHES FOR THE TREATMENT OF LOW-RISK EC WITH SLN MAPPING. RSS REDUCES SURGICAL TIME. IN TERMS OF QOL, BODY IMAGE AND COSMETIC RESULTS, NO DIFFERENCES WERE OBSERVED BETWEEN THE TWO APPROACHES WITH REGARD TO BODY IMAGE AND COSMETIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201548 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1