BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11904982 · Received May 28, 2021

    Report

    Report Number
    2210968-2021-05080
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    June 22, 2012
    Report Date
    April 30, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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. CITATION: INT UROGYNECOL J (2013) 24:47¿54. DOI 10.1007/S00192-012-1844-6. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADVERSE EVENTS ASSOCIATED WITH TENSION FREE VAGINAL TAPE DEVICE REPORTED VIA MW # 2210968-2021-05079.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: WHICH WOMEN DEVELOP URGENCY OR URGENCY URINARY INCONTINENCE FOLLOWING MIDURETHRAL SLINGS? THE AIM OF THIS RETROSPECTIVE STUDY IS TO DETERMINE WHAT RISK FACTORS LEAD TO THE DEVELOPMENT OF BOTH DU AND DUUI FOLLOWING MUS PROCEDURES IN WOMEN WHO PREVIOUSLY HAD NO SUCH SYMPTOMS. BETWEEN MAY 1999 TO AUGUST 2008, A TOTAL OF 598 FEMALE PATIENTS (MEAN AGE = (B)(6) YEARS), OF WHICH 358 HAD SUI ONLY (HAD NO URGENCY OR UUI AT BASELINE) AND 240 HAD SUI AND URGENCY (HAD NO UUI AT BASELINE), UNDERWENT MUS AND WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING EITHER OF TVT (GYNECARE; ETHICON), TVT-O (GYNECARE; ETHICON), OR COMPETITOR DEVICES. THE MEAN FOLLOW-UP WAS 50 MONTHS. REPORTED COMPLICATIONS INCLUDED DE NOVO URGENCY (N=?), DE NOVO URGENCY URINARY INCONTINENCE (N=?), OCCULT STRESS INCONTINENCE (N=?), URODYNAMIC STRESS INCONTINENCE (N=?), DETRUSOR OVERACTIVITY (N=?), INTRINSIC SPHINCTER DEFICIENCY (N=?), BLADDER PERFORATION (N=?), AND UNKNOWN EVENT (N=?) WHICH REQUIRED A REPEAT ANTI-INCONTINENCE SURGERY, RETROPUBIC MUS OR TRANSOBTURATOR MUS. IN CONCLUSION, PREVIOUS STRESS INCONTINENCE OR PROLAPSE SURGERY, PRESENCE OF URODYNAMIC ISD OR COEXISTENT DO (WITH USI) SIGNIFICANTLY INCREASED, WHEREAS CONCOMITANT APICAL PROLAPSE SURGERY SIGNIFICANTLY DECREASED THE RISK OF WOMEN DEVELOPING DU/DUUI FOLLOWING MUS. URODYNAMIC PARAMETERS AND CONCOMITANT APICAL PROLAPSE OPERATION FOR CONCURRENT LARGE PROLAPSE ARE IMPORTANT PREDICTORS IN THE DEVELOPMENT OF DU/ DUUI FOLLOWING MUS PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799104 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention