BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7928954 · Received October 2, 2018

    Report

    Report Number
    2210968-2018-76248
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TENSION FREE VAGINAL TAPE - OBTURATOR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 214 (2017) 6¿10; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2017.04.038. (B)(4).

    Description of Event or Problem · 1

    TITLE: "UROFLOWMETRIC CHANGES, SUCCESS RATE AND COMPLICATIONS FOLLOWING TENSION-FREE VAGINAL TAPE OBTURATOR (TVT-O) OPERATION IN OBESE FEMALES". THIS PROSPECTIVE OBSERVATION STUDY AIMED TO EVALUATE THE OUTCOME OF TENSION-FREE VAGINAL TAPE OBTURATOR (TVT-O) OPERATION IN THE TREATMENT OF URODYNAMIC STRESS INCONTINENCE (USI) IN OBESE FEMALES, WITH RESPECT TO UROFLOWMETRIC CHANGES, SUCCESS RATE AND POSTOPERATIVE COMPLICATIONS. A TOTAL OF 26 FEMALE OBESE PATIENTS (MEAN AGE SD OF 43.58 [9.01] YEARS; BMI SD OF 33.4 [2.1] KG/M2) WITH URODYNAMIC STRESS INCONTINENCE UNDERWENT TVT-O OPERATION USING GYNECARE TVT OBTURATOR SYSTEM WHICH WAS PLACED STARTING IN THE GROIN AREA, PASSING THROUGH THE OBTURATOR FORAMEN, AND THEN INTO THE VAGINA (¿OUT-TO-IN¿). THE SKIN AND THE VAGINAL INCISIONS WERE CLOSED BY NO. 2-0 VICRYL INTERRUPTED SUTURES. THERE WERE 5 CASES OF TVT-O FAILURES REPORTED. POSTOPERATIVE COMPLICATIONS INCLUDED GROIN PAIN AT WEEK 1 (N=84.62%), AT 1ST MONTH (N=65.38%), AT 3RD MONTH (N=34.62%), AND AT 6TH MONTH (N=32.62%); SENSE OF INCOMPLETE EMPTYING AT WEEK 1 (N=61.54%), AND AT 6TH MONTH (N=50%); STRAINING FOR MICTURITION AT WEEK 1 (N=15.4%) AND AT 6TH MONTH (N=23%); URGENCY AT WEEK 1 (N=61.54%), AND AT 6TH MONTH (N=26.92%); URINARY TRACT INFECTION AT WEEK 1 (N=16), AT 1ST MONTH (N=12), AT 3RD MONTH (N=7), AND AT 6TH MONTH (N=4); ESCAPE OF URINE UPON COUGH AT WEEK 1 (N=6), AT 1ST MONTH (N=5), AT 3RD MONTH (N=5) AND AT 6TH MONTH (N5); VAGINITIS AT 1ST MONTH (N=6), AT 3RD MONTH (N=2) AND AT 6TH MONTH (N=4). IT WAS REPORTED THAT SURGICAL INTERVENTIONS USED FOR TREATMENT OF INCONTINENCE MAY AFFECT THE BLADDER OUTLET RESISTANCE LEADING TO VOIDING DYSFUNCTION. THE CAUSE OF THE HIGH INCIDENCE OF URGENCY IN THE EARLY POSTOPERATIVE PERIOD IS ASSOCIATED URINARY TRACT INFECTION (UTI) RATHER THAN THE IRRITATIVE EFFECT OF THE MIDURETHERAL SLING AS WE FOUND THAT ONLY ONE PATIENT COMPLAINED OF URGENCY WITHOUT HAVING UTI. TVT-O OPERATION SHOWED A HIGH SUCCESS RATE IN TREATMENT OF URODYNAMIC STRESS INCONTINENCE IN OBESE PATIENTS WITHOUT AFFECTING THE VOIDING FUNCTION OF THE BLADDER AS PROVEN BY THE UROFLOWMETRIC PARAMETERS. THE MAIN POSTOPERATIVE COMPLAINT WAS THE GROIN PAIN WHICH SIGNIFICANTLY IMPROVED AFTER ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767687 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention