BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 9212489 · Received October 20, 2019

    Report

    Report Number
    2210968-2019-88845
    Event Type
    Injury
    Date Received
    October 20, 2019
    Report Date
    September 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TVT-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 (TVT-OBTURATOR ) INVOLVED? PATIENT DEMOGRAPHICS. CITATION: PAK J MED SCI. 2019;35(2):477-482. DOI: HTTPS://DOI.ORG/10.12669/PJMS.35.2.603.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: THE OUTCOMES OF TRANSOBTURATOR TAPE INTERVENTION IN THE TREATMENT OF STRESS URINARY INCONTINENCE: TWO YEARS¿ FOLLOW-UP THE OBJECTIVE OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE CLINICAL OUTCOMES AND THE EFFECTS ON QUALITY OF LIFE OF TRANSOBTURATOR TAPE (TOT) SURGERY DURING A 2-YEAR FOLLOW-UP PERIOD IN OUR CLINICS. THE AUTHORS REPORTED THAT TOT SURGERY COMPRISES THE PLACEMENT OF A SLING MATERIAL UNDER URETHRA WITH A TRANSOBTURATOR APPROACH. BETWEEN 2011 AND 2013, 87 PATIENTS (MEAN AGE 46.55 ± 5.74 YEARS, AGE RANGE 37 ¿ 56 YEARS; BMI 30.9 ± 4.57) WHO HAD SYMPTOMS OF URINARY INCONTINENCE AND WERE DIAGNOSED AS HAVING STRESS URINARY INCONTINENCE (SUI) OR MIXED URINARY INCONTINENCE (MUI) UNDERWENT TRANSOBTURATOR TAPE SURGERY USING TVT-OBTURATOR INSIDE-OUT/PROLENE BAND (ETHICON). CYSTOSCOPIES WERE PERFORMED AFTER THE PROCEDURE TO CHECK THE BLADDER AND URETHRA. IN PATIENTS WHO REQUIRED IT, ADDITIONAL PROCEDURES WERE PERFORMED AFTER THE PLACEMENT OF THE PROLENE BAND AND THE PATIENT WAS ASKED TO COUGH IN ORDER TO ADJUST THE TENSION OF THE BAND. COLPORRHAPHY ANTERIOR (CA) WAS ADDITIONALLY PERFORMED ON 28 PATIENTS AND COLPORRHAPHY POSTERIOR (CP) WAS ADDITIONALLY PERFORMED ON 4 PATIENTS DURING THE OPERATION. TOT PROCEDURES ALONE WERE PERFORMED ON 59 PATIENTS. REPORTED COMPLICATIONS INCLUDED PERINEAL PAIN (N=3) WHICH THE PATIENTS WERE TREATED WITH ANALGESICS AND COLD PACKS; DE NOVO URGE INCONTINENCE (N=5) WHICH THE PATIENTS WERE TREATED WITH ANTICHOLINERGICS; VAGINAL MESH EROSION (N=2) WHICH THE PATIENTS WERE IN FULL RECOVERY AFTER AN EXCISION. IN CONCLUSION, THE STUDY REVEALED A HIGH OBJECTIVE CURE RATE, AND AN IMPROVEMENT IN SYMPTOMS AND QUALITY OF LIFE WITH THE TRANSOBTURATOR TAPE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006750 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention