BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18997548 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03548
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. CITATION: J PEDIATR ADOLESC GYNECOL 36 (2023) 33¿38 HTTPS://DOI.ORG/10.1016/J.JPAG.2022.09.002.

    Description of Event or Problem · 0

    TITLE: POSTOPERATIVE VAGINAL BLEEDING CONCERNS AFTER GENDER-AFFIRMING HYSTERECTOMY IN TRANSGENDER ADOLESCENTS AND YOUNG ADULTS ON TESTOSTERONE. THIS STUDY AIMED TO CHARACTERIZE THE INCIDENCE AND MANAGEMENT OF POSTOPERATIVE VAGINAL BLEEDING CONCERNS EXPERIENCED BY TRANSGENDER ADOLESCENTS AND YOUNG ADULTS (AYA) ON TESTOSTERONE HORMONE THERAPY AFTER GENDER-AFFIRMING HYSTERECTOMY (GAH). BETWEEN JULY 2020 AND SEPTEMBER 2021, A TOTAL OF 25 PATIENTS WITH A MEAN AGE OF 19 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT A GENDER-AFFIRMING HYSTERECTOMY (GAH). UPON SURGERY, A ROUTE OF VAGINAL CUFF CLOSURE WAS DETERMINED AT THE SURGEON¿S DISCRETION. A LAPAROSCOPIC VAGINAL CUFF CLOSURE WAS PERFORMED IN 15 PATIENTS USING A 2-0 V-LOC SUTURES, WHEREAS VAGINAL CUFF CLOSURE APPROACH WAS PERFORMED IN 9 PATIENTS USING 0-VICRYL SUTURES. PATIENTS WERE TYPICALLY DISCHARGED ON POSTOPERATIVE DAY 1, AND THEY WERE SEEN FOR POSTOPERATIVE VISITS 2 WEEKS AND 8 WEEKS AFTER SURGERY WITH PELVIC EXAMINATION AND COUNSELLING. REPORTED COMPLICATION WAS BLEEDING CONCERNS CAUSED BY THE FOLLOWING: GRANULATION TISSUE, VAGINAL ATROPHY, VAGINAL MUCOSAL SEPARATION, BLEEDING SUBMUCOSAL VESSEL, AND NO CAUSE FOUND. CONCLUSIONS: OVER HALF OF TRANSGENDER AYA ON TESTOSTERONE THERAPY IN THIS COHORT REPORTED POSTOPERATIVE VAGINAL BLEEDING CONCERNS THAT WERE MOST OFTEN SECONDARY TO ATROPHY AND GRANULATION TISSUE, SUGGESTING POSSIBLE SUSCEPTIBILITY TO VAGINAL TISSUE TRAUMA AT THE TIME OF GAH AND GRANULATION-SUSCEPTIBLE HEALING IN PATIENTS ON TESTOSTERONE. AS VAGINAL BLEEDING COULD WORSEN GENDER DYSPHORIA, THESE FINDINGS SUPPORT THE NEED FOR PATIENT COUNSELING ON POSTOPERATIVE BLEEDING EXPECTATIONS AND IDENTIFICATION OF INTERVENTIONS TO REDUCE VAGINAL BLEEDING AFTER GAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468220 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention