BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12441640 · Received September 8, 2021

    Report

    Report Number
    2210968-2021-08155
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    January 1, 2020
    Report Date
    August 26, 2021
    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 · 1

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: UROLOGY (2020); 146:72-78. DOI: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2020.09.018.

    Description of Event or Problem · 1

    TITLE: MODIFIED AUTOLOGOUS TRANSOBTURATOR TAPE SURGERY - A PROSPECTIVE COMPARISON WITH TRANSOBTURATOR TAPE SURGERY. THE AIM OF THIS PROSPECTIVE, NONRANDOMIZED COHORT TRIAL WAS TO COMPARE MODIFIED AUTOLOGOUS TRANSOBTURATOR-TAPE (A-TOT) AND TRANSOBTRATOR-TAPE (TOT) SURGERIES IN TERMS OF EFFECTIVITY AND COMPLICATIONS. BETWEEN DECEMBER 2017 AND MARCH 2019, A TOTAL OF 117 PATIENTS WITH UNCOMPLICATED SUI WERE INCLUDED IN THE STUDY. A-TOT WAS PERFORMED IN 36 PATIENTS (MEAN AGE = 50.8 ± 9.3 YEARS; MEAN BMI = 29.0 ± 4.1) WITH AUTOLOGOUS FASCIA ELONGATED WITH TWO 2-0 NONABSORBABLE POLYESTER STAY SUTURES (ETHIBOND, ETHICON, NEW JERSEY). THE MEAN FOLLOW-UP TIME WAS 21.5 ± 1.1 MONTHS. REPORTED COMPLICATIONS INCLUDED VAGINAL EXPOSURE (N=1) TREATED WITH TOPICAL ESTRADIOL, VAGINITIS (N=1) TREATED WITH TOPICAL ANTIBIOTICS, POSITIVE COUGH STRESS TEST (N=1), PGI-I SCORE >2 (N=1), AND INCREASED PVR (N=?). IN CONCLUSION, THE A-TOT TECHNIQUE HAS COMPARABLE OBJECTIVE CURE AND SUBJECTIVE CURE RATES WITH THE TOT TECHNIQUE, WITH SIMILAR OVERALL COMPLICATION RATES. THE USE OF THE A-TOT TECHNIQUE PROVIDES THE OPPORTUNITY TO AVOID MESH-RELATED COMPLICATIONS AND HAS BETTER RESULTS COMPARED TO THE TOT TECHNIQUE IN TERMS OF POSTOPERATIVE VOIDING DYSFUNCTION AND DE NOVO FILLING PHASE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337008 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention