BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT

    MDR report key: 7945145 · Received October 8, 2018

    Report

    Report Number
    2210968-2018-76389
    Event Type
    Injury
    Date Received
    October 8, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? NO DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? NO

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. 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 PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2014) 25:909¿914; DOI 10.1007/S00192-013-2312-7 -(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: RANDOMIZED CLINICAL TRIAL COMPARING TVT SECUR SYSTEM AND TRANS VAGINAL OBTURATOR TAPE FOR THE SURGICAL MANAGEMENT OF STRESS URINARY INCONTINENCE" AUTHOR: KEN MASLOW & CHANDER GUPTA & PETER KLIPPENSTEIN & LISE GIROUARD CITATION: INT UROGYNECOL J (2014) 25:909¿914; DOI 10.1007/S00192-013-2312-7. THIS PROSPECTIVE RANDOMIZED STUDY AIMED TO COMPARE THE SAFETY AND EFFICACY OF THE TVT SECUR (TVT-S) WITH THE TRANS-VAGINAL OBTURATOR TAPE (TVT-O) FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING THE STUDY PERIOD, 106 FEMALE PATIENTS WITH STRESS URINARY INCONTINENCE UNDERWENT SURGERY USING EITHER TVT-S (N=56 AGE OF 48.75, 9.3 YEARS) OR TVT-O (AGE OF 48.7, 8.3 YEARS). IN TVT-S GROUP, HAMMOCK POSITION TECHNIQUE WAS USED. INTRAOPERATIVE FINDING INCLUDED ONE PATIENT WITH BLADDER INJURY IN TVT-S GROUP WHICH REQUIRED MESH REMOVAL WITH SUBSEQUENT SURGERY. INITIAL POSTOPERATIVE GROIN PAIN WAS PRESENT ON TVT-O GROUP (N=48) AND TVT-S GROUP (N=27). POSTOPERATIVE ONE YEAR OUTCOME INCLUDED SUBJECTIVE SUI (N=6 TVT-O GROUP, N=14 TVT-S GROUP), PAD USE (N=7 TVT-O GROUP, N=14 TVT-S GROUP), VAGINAL DISCOMFORT (N=1 TVT-S GROUP), GROIN DISCOMFORT (N=3 TVT-O GROUP), DYSPAREUNIA (N=6 TVT-O GROUP, N=3 TVT-S GROUP), VAGINAL EROSION (N=1 TVT-S GROUP), AND ATROPHIC VAGINA (N=17 TVT-O GROUP, N=16 TVT-S GROUP). TVT-O WAS SUPERIOR TO TVT-S IN THE OBJECTIVE CURE OF STRESS URINARY INCONTINENCE AT 1-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785039 TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL PAH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention