BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8219253 · Received January 4, 2019

    Report

    Report Number
    2210968-2019-78193
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. CITATION: INT UROGYNECOL J. 2012; 23: 197¿206. DOI: 10.1007/S00192-011-1543-8 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : TWELVE MONTHS EFFECT ON VOIDING FUNCTION OF RETROPUBIC COMPARED WITH OUTSIDE-IN AND INSIDE-OUT TRANSOBTURATOR MIDURETERAL SLINGS" AUTHOR: DAVID A. SCHEINER & CORNELIA BETSCHART & SANDRA WIEDERKEHR & BURKHARDT SEIFERT & DANIEL FINK & DANIELE PERUCCHINI CITATION: INT UROGYNECOL J. 2012; 23: 197¿206. DOI: 10.1007/S00192-011-1543-8. THE PURPOSE OF THIS STUDY IS TO COMPARE RETROPUBIC TENSION-FREE VAGINAL TAPE (TVT) WITH TRANSOBTURATOR OUT-IN TOT AND IN-OUT TVT-O FOR FEMALE STRESS URINARY INCONTINENCE. A TOTAL OF 80 TVT (AGE: 33.9 TO 85.4 YEARS; BMI: 18.9 TO 35.9), 40 TOT (AGE: 40.5 TO 84.8 YEARS; BMI: 18.7 TO 41.5), AND 40 TVT-O CASES (AGE: 33.9 TO 81.8 YEARS; BMI: 19.2 TO 39.2) WERE RANDOMIZED. FOR THE TVT GROUP, GYNECARE TVT (ETHICON) WAS USED; FOR THE TVT-O GROUP, GYNECARE TVT-O (ETHICON) WAS USED. IN THE TVT GROUP, REPORTED COMPLICATIONS INCLUDED INCONTINENT (FAILURE; N-2), VOIDING OBSTRUCTION (N-3) WHICH REQUIRED TAPE LOOSENING WITHIN THE FIRST WEEK IN 1 PATIENT AND TAPE RELEASE PROCEDURE IN 2 PATIENTS, PERSISTENT DE NOVO URGE (N-1) WHICH REQUIRED RELEASE AFTER 6 MONTHS, VAGINAL TAPE EXPOSURE (N-1) WHICH REQUIRED PARTIAL EXCISION OF THE TVT, THIGH OR GROIN PAIN (N-1), FEMALE SEXUAL DYSFUNCTION (N-2). IN THE TVT-O GROUP, REPORTED COMPLICATIONS INCLUDED INCONTINENT (FAILURE; N-3), VOIDING OBSTRUCTION (N-1) WHICH REQUIRED TAPE RELEASE PROCEDURE IN 1 PATIENT, THIGH OR GROIN PAIN (N-1), FEMALE SEXUAL DYSFUNCTION (N-4). WOMEN SHOULD BE INFORMED OF THESE POTENTIAL COMPLICATIONS PREOPERATIVELY AND REQUIRE CAREFUL FOLLOW-UP AFTER THE PROCEDURE. FURTHER STUDIES SHOULD FOCUS ON LONG-TERM FOLLOW-UP AND THE COMPLICATION PATTERN PARTICULARLY FOR THE CURRENT SLINGS, AS WELL AS ON A POSSIBLE DIFFERENTIAL INDICATION, SUCH AS TVT FOR YOUNGER PATIENTS OR FOR PATIENTS WITH LOW-PRESSURE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9078 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention