BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7940687 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76355
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCT (TENSION FREE VAGINAL TAPE) 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 INVOLVED? CITATION: CAN UROL ASSOC J. 2015; 9(3-4): E208-9. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.2680. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : DELAYED SIGMOID COLON PERFORATION AND ENTEROCUTANEOUS FISTULA DUE TO TENSION FREE TRANSVAGINAL TAPE OPERATION FOR STRESS URINARY INCONTINENCE" AUTHOR: IN KYU LEE, MD, PHD;* DONG WAN SOHN MD, PHD CITATION: CAN UROL ASSOC J. 2015; 9(3-4): E208-9. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.2680. THE AUTHORS RECENTLY EXPERIENCED THE CASE OF DELAYED DETECTED SIGMOID COLON PERFORATION AND ENTEROCUTANEOUS FISTULA DUE TO TVT TAPE OPERATION AFTER 7 YEARS. A (B)(6) FEMALE PATIENT COMPLAINED OF LEFT LOWER ABDOMINAL TENDERNESS AND SWELLING FOR 2 WEEKS. HER RIGHT THIGH WAS ALSO TENDER AND SWOLLEN. THE PATIENT UNDERWENT TVT PROCEDURE USING GYNECARE TVT (ETHICON) 7 YEARS AGO. FIVE MONTHS PRIOR TO PRESENTATION, IT WAS REPORTED THAT THE PATIENT HAD PRIOR VAGINAL EROSION OF THE TVT TAPE WHICH REQUIRED REMOVAL OF THE SUBURETHRAL POLYPROPYLENE MESH. HOWEVER AT THAT TIME, COMPLETE REMOVAL OF THE MESH WAS IMPOSSIBLE BECAUSE PULLING THE RIGHT PART RESULTED IN SNAPPING OF THE MESH ADHERED TO THE TISSUE. THE PATIENT¿S COMPUTED TOMOGRAPHY EXAMINATION REVEALED PERFORATION OF SIGMOID COLON, ENTEROCUTANEOUS FISTULA, AND SUBCUTANEOUS ABSCESS WHICH REQUIRED LAPAROSCOPIC SIGMOID COLON WEDGE RESECTION AND EXCISION OF THE MESH COMPLETELY IN SIGMOID COLON AND PERITONEAL WALL. IT WAS REPORTED THAT WHEN AN ANTI-SUI SURGERY IS PERFORMED, THE SURGEON SHOULD BE WARY TO PREVENT BOWEL INJURY. IF BOWEL INJURY IS SUSPECTED, IMMEDIATE EXPLORATORY LAPAROTOMY IS NECESSARY. LAPAROSCOPIC SURGERY IS SAFE AND EFFICACIOUS METHOD TO REMOVE THE TAPE AND REPAIR THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781559 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention