BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 8226736 · Received January 8, 2019

    Report

    Report Number
    2210968-2019-78266
    Event Type
    Injury
    Date Received
    January 8, 2019
    Report Date
    December 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE 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 (2016) 27:1925¿1927; DOI 10.1007/S00192-016-3085-6. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: TRANSVAGINAL REPAIR OF A URETHROVAGINAL FISTULA USING THE LATZKO TECHNIQUE WITH A BULBOCAVERNOSUS (MARTIUS) FLAP" AUTHOR(S): ARIEL ZILBERLICHT & YUVAL LAVY & RON AUSLENDER & YORAM ABRAMOV CITATION: INT UROGYNECOL J (2016) 27:1925¿1927; DOI 10.1007/S00192-016-3085-6. THIS STUDY AIMED TO PRESENT A (B)(6) YEAR-OLD FEMALE PATIENT WITH SEVERE URINARY STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY WHO UNDERWENT TENSION-FREE VAGINAL TAPE (TVT, ETHICON) PROCEDURE. TWO WEEKS LATER, SHE UNDERWENT URETHROLYSIS (CUTTING OF THE TAPE) FOR URINARY RETENTION WHICH ALLEVIATED HER CONDITION, BUT RESULTED IN CONTINUOUS URINE LEAKAGE AGGRAVATION BY COUGHING, SNEEZING AND WALKING. PELVIC EXAMINATION AND CYSTOURETHROSCOPY REVEALED A 3-MM URETHROVAGINAL FISTULA AT THE MIDDLE THIRD OF HER URETHRA. SHE UNDERWENT TRANSVAGINAL REPAIR OF HER FISTULA USING THE LATZKO TECHNIQUE WITH A BULBOCAVERNOSUS (MARTIUS) FLAP. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL. AT HER FOLLOW-UP VISIT 2 MONTHS LATER, SHE WAS FREE OF URINARY LEAKAGE, AND PELVIC EXAMINATION REVEALED EXCELLENT HEALING WITH COMPLETE CLOSURE OF THE FISTULA. URETHROVAGINAL FISTULA IS A RARE COMPLICATION OF THE SYNTHETIC MIDURETHRAL SLING THAT GENERALLY PRESENTS WITH MASSIVE URINARY LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19296 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention