BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7931593 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76287
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 10, 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. 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 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 ¿ OBTURATOR) 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: J GYNECOL OBSTET HUM REPROD 46 (2017) 103¿105; DOI: HTTP://DX.DOI.ORG/10.1016/J.JOGOH.2016.11.006. (B)(4).]

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : VAGINOCUTANEOUS FISTULA AND BUTTOCK ABSCESS FORMATION 7 YEARS AFTER POLYPROPYLENE TRANSOBTURATOR TAPE INSERTION" AUTHOR: ALAIN. ABDALLAH , M. NISOLLE , L. DE LANDSHEERE CITATION: J GYNECOL OBSTET HUM REPROD 46 (2017) 103¿105; DOI: HTTP://DX.DOI.ORG/10.1016/J.JOGOH.2016.11.006. THIS CASE REPORT AIMED TO PRESENT A (B)(6) FEMALE PATIENT WITH STRESS URINARY INCONTINENCE WHO UNDERWENT INSERTION OF TRANSOBTURATOR TAPE (GYNECARE TVT-O). AFTER 6 YEARS, THE PATIENT DEVELOPED VAGINAL TAPE EXPOSURE AND UNDERWENT REPAIR OF WHICH THE DEFECT WAS PRIMARILY CLOSED AND MESH WAS LEFT IN PLACE. A YEAR LATER, SHE COMPLAINED OF PAIN AND PURULENT DISCHARGE FROM HER LEFT BUTTOCK. SINUS IN THE LEFT BUTTOCK DRAINING PURULENT FLUID ALONG WITH AN ABSCESS FORMATION WAS IDENTIFIED WHICH WAS TREATED BY INCISION AND DRAINING, WITH ANTIBIOTIC COVERAGE. AFTER ABSCESS DRAINAGE, MRI SHOWED PRESENCE OF A FISTULOUS TRACT FROM THE URETHROVAGINAL MUCOSA WILL THE LEFT ISCHIO-RECTAL AND ISCHO-ANAL FOSSAS, TREATED WITH SHARP EASY DISSECTION OF THE DEFECT LEADING TO THE LEFT ARM OF THE TAPE WHICH WAS THEN RESECTED BY SIMULTANEOUS DISSECTION AND TRACTION. THREE DAYS LATER, SINUS DRAINAGE STOPPED. STRESS URINARY INCONTINENCE DID NOT RECUR IN THIS PATIENT AFTER MESH REMOVAL. THE RISK FOR MESH EXPOSURE WAS DIRECTLY ASSOCIATED WITH THE TYPE OF MATERIAL USED DURING SUBURETHRAL SLING PROCEDURES AND THIS COULD BE DUE TO THE TENDENCY FOR BACTERIAL COLONIZATION OF THE MESH USED. SUSPICION OF FISTULA FORMATION SHOULD RISE IN PATIENTS PRESENTING WITH BOTHERSOME VAGINAL OR CUTANEOUS DISCHARGE AFTER TRANSOBTURATOR TAPE INSERTION. THIS CASE IS PARTICULAR SINCE IT DESCRIBES A FISTULA COMPLICATION WITH POLYPROPYLENE TAPE, WHICH IS UNUSUAL WITH THIS TYPE OF TAPES. TREATMENT OF SUCH COMPLICATION SHOULD ALWAYS CONSIST OF SURGICAL REMOVAL OF THE MESH TO ALLOW CLOSURE OF THE FISTULOUS TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772796 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention