BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16572100 · Received March 20, 2023

    Report

    Report Number
    2210968-2023-01787
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    June 23, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2023) 34:231¿238. HTTPS://DOI.ORG/10.1007/S00192-022-05267-6.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF LAPAROSCOPIC LATERAL SUSPENSION AND LAPAROSCOPIC SACROCOLPOPEXY WITH CONCURRENT TOTAL LAPAROSCOPIC HYSTERECTOMY FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL. THIS RANDOMIZED CLINICAL TRIAL AIMED TO COMPARE PATIENTS UNDERGOING LAPAROSCOPIC LATERAL SUSPENSION WITH CONCURRENT TOTAL LAPAROSCOPIC HYSTERECTOMY (LLS-TLH) AND LAPAROSCOPIC SACROCOLPOPEXY WITH CONCURRENT TOTAL LAPAROSCOPIC HYSTERECTOMY (LSC-TLH) IN TERMS OF OBJECTIVE AND SUBJECTIVE OUTCOMES, PATIENT SATISFACTION, AND INTRA- AND POSTOPERATIVE COMPLICATIONS. BETWEEN JANUARY 2019 AND JANUARY 2020, A TOTAL OF 80 FEMALE PATIENTS WITH PROLAPSE-RELATED SYMPTOMS WERE RANDOMIZED TO THE LLS-TLH (N=40; MEAN AGE WAS 59.4 ± 8.6 YEARS) AND LSC-TLH (N=40; MEAN AGE WAS 59.4 ± 8.8 YEARS) GROUPS. IN LLS-TLH GROUP, A COMPETITOR MESH WAS FIXED TO THE ANTERIOR¿SUPERIOR VAGINAL WALL WITH NUMBER 0 NON-RESORBABLE POLYESTER SUTURES (ETHIBOND; ETHICON, SOMERVILLE, NJ, USA). IN LSC-TLH GROUP, A COMPETITOR MESH WAS ATTACHED TO THE SACRAL PROMONTORY USING A COMPETITOR STAPLES, AND THE OTHER END OF THE MESH WAS SUTURED WITH NUMBER 0 NON-RESORBABLE POLYESTER SUTURES (ETHIBOND) TO THE ANTERIOR AND POSTERIOR VAGINAL WALLS. REPORTED COMPLICATIONS INCLUDE RECURRENCES FOR PELVIC ORGAN PROLAPSE (N=17), DE NOVO POSTERIOR VAGINAL WALL DEFECT (N=7), STRESS URINARY INCONTINENCE (N=14), DE NOVO STRESS URINARY INCONTINENCE (N=5), URGE URINARY INCONTINENCE (N=10), DE NOVO URGE URINARY INCONTINENCE (N=2), AND MIXED URINARY INCONTINENCE (N=6). IN CONCLUSION, LLS-TLH CAN SERVE AS A SAFE, EFFECTIVE, AND FEASIBLE ALTERNATIVE TO LSC-TLH, WITH LOW COMPLICATION RATES AND SIMILAR SHORT-TERM OBJECTIVE AND SUBJECTIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12942 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention