BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 19282000 · Received May 9, 2024

    Report

    Report Number
    2210968-2024-05308
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    May 2, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. AN ATTEMPT HAS BEEN 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. RELATED EVENTS CAPTURED VIA 2210968-2024-05307. CITATION: DOI:10.16193/J.CNKI.HNWK .2020.05.073. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: SHORT-TERM EFFECT OF SELF-MADE ADJUSTABLE SLING FOR TRANSVAGINAL TENSION-FREE URETHRAL SLING VIA RETROPUBIC APPROACH IN THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE. THE AIM OF THE STUDY IS TO INVESTIGATE THE SHORT-TERM EFFECT OF SELF-MADE ADJUSTABLE SLING IN THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI) BY RETROPUBIC TRANSVAGINAL TENSION-FREE URETHRAL SLING (TVT). THE CLINICAL DATA OF 37 FEMALE PATIENTS WITH SUI WHO UNDERWENT TVT IN THE DEPARTMENT OF UROLOGY, FROM JANUARY 2018 TO JANUARY 2020 WERE RETROSPECTIVELY ANALYZED. TVT WAS PERFORMED USING AN ADJUSTABLE SLING MADE BY THE HERNIA PATCH. (TVT JOHNSON & JOHNSON), CUT INTO A DOUBLE-LAYER SLING OF 1.0 CM × 8.0 CM, AND USE 2 - 0 ABSORBABLE SUTURES FIX THE SLING ENDS TO MAKE A SLING. WITH PEDIATRIC HERNIA NEEDLE SUSPENSION LINE. EMPTY THE BLADDER BELOW THE URETHRAL MEATUS. A 2 CM LONGITUDINAL INCISION WAS MADE AT 1 CM. DISSECT URETHRA AND ANTERIOR VAGINAL WALL TO PALPABLE. THE MEDIAL BORDER OF THE DESCENDING BRANCH OF THE BONE, AND THE MIDDLE URETHRA WERE MOBILIZED. THE REPORTED COMPLICATIONS INCLUDED (N=3) DYSURIA TREATMENT: TRANSURETHRAL DILATATION AND ADJUSTMENT OF THE SLING, (N=3) URINARY RETENTION TREATMENT: TRANSURETHRAL DILATATION AND ADJUSTMENT OF THE SLING, (N=1) SLING EROSION TREATMENT: REOPERATION TO REMOVE THE SLING. IN CONCLUSION, TVT WITH SELF-MADE ADJUSTABLE SLING FOR FEMALE PATIENTS WITH SUI IS SIMPLE, LESS COMPLICATIONS, LOW COST, EASY TO PROMOTE, POSTOPERATIVE SLING CAN BE ADJUSTED ACCORDING TO THE EFFECT, THE OVERALL RESPONSE RATE IS HIGH IN THE NEAR FUTURE. LONG-TERM RESULTS STILL NEED TO BE FOLLOWED UP AND OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358414 SUTURE UNKNOWN SUTURE, ABSORBABLE GAK ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention