BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 9258562 · Received October 30, 2019

    Report

    Report Number
    2210968-2019-89290
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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-OBURATOR ) 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 (TENSION-FREE VAGINAL TAPE-OBURATOR) INVOLVED? CITATION: UROL INT 2019;103:223¿227, DOI: 10.1159/000501287. (B)(4).

    Description of Event or Problem · 1

    TITLE : NO TREATMENT REQUIRED FOR ASYMPTOMATIC VAGINAL MESH EXPOSURE. THE AIM OF THIS MULTICENTER PROSPECTIVE STUDY IS TO EVALUATE THE OPTION ¿WAIT AND SEE,¿ AVOIDING UNNECESSARY SURGICAL PROCEDURES IN ASYMPTOMATIC PATIENTS WITH MESH EXPOSURE AFTER FAILURE OF LOCAL THERAPY. FROM APRIL 2014 TO MAY 2018, A TOTAL OF 40 WOMEN (MEAN AGE 61.3 YEARS) WITH VAGINAL MESH EXPOSURE AFTER ANTI-INCONTINENCE OR PROLAPSE SURGERY (BY ABDOMINAL AND VAGINAL APPROACH). OF THESE PATIENTS, 3 WOMEN UNDERWENT ANTI-INCONTINENCE SURGERY USING TENSION-FREE VAGINAL TAPE-OBTURATOR (TVT-O) (GYNECARE JOHNSON AND JOHNSON). COMPLAINT INCLUDED MESH EXPOSURE (N=3) IN LEFT VAGINAL FORNIX FROM THE TVT-O GROUP. EXPOSURES WERE =1 CM (MEAN 6.5 ± 1.5 MM, RANGE 4¿10 MM (CATEGORY 2), ASYMPTOMATIC, AND WITHOUT PAIN. THE RESULTS OF THIS STUDY SHOWED THAT THE SURGICAL TREATMENT SHOULD BE CONSIDERED IN CASES OF URINARY TRACT OR BOWEL EXTRUSION OR IN SYMPTOMATIC PATIENTS. NEVERTHELESS, IN CASES OF EXPOSURE LIMITED TO THE VAGINA (=1 CM) IN ASYMPTOMATIC WOMEN, SUCH AS THOSE IN OUR STUDY, OBSERVATION IS A VALID OPTION AND THE VISITS OF FOLLOW-UP COULD ALSO BE PERFORMED ANNUALLY AS WELL AS IN PATIENTS WITHOUT EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052118 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention