BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 14256721 · Received April 29, 2022

    Report

    Report Number
    2210968-2022-03175
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    January 11, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (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.  CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL, HTTPS://DOI.ORG/10.1007/S00192-021-05014-3. 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. 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 (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? PATIENT DEMOGRAPHICS?

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SONOGRAPHIC ASSESSMENT OF COMPRESSION EFFECT ON URETHRA FOLLOWING TRANSOBTURATOR MUS. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN COMPRESSION EFFECT EXERTED BY THE SLING ON THE URETHRA USING TRANSLABIAL ULTRASOUND AND THE PROGNOSIS OF SLING SURGERY IN WOMEN FOR STRESS URINARY INCONTINENCE. BETWEEN JANUARY 2017 AND DECEMBER 2020, 151 WOMEN (MEAN AGE OF 56 YEARS, SD 11) WITH STRESS URINARY INCONTINENCE WHO HAD UNDERGONE TVT SURGERY AND COMPLETED 12-MONTH FOLLOW-UP WERE INCLUDED IN THE STUDY. 81 UNDERWENT TVT-ABBREVO (GYNECARE, ETHICON) SURGERY AND 70 UNDERWENT TVT-O (GYNECARE, ETHICON). ROUTINE ASSESSMENTS PERFORMED 12 MONTHS AFTER THE PROCEDURES INCLUDED PELVIC EXAMINATIONS, URINALYSIS, URODYNAMIC STUDY, 3D TRANSLABIAL ULTRASONOGRAPHY AND PERSONAL INTERVIEWS USING THE INTERNATIONAL CONSULTATION ON INCONTINENCE QUESTIONNAIRE AND PATIENT GLOBAL IMPRESSION OF IMPROVEMENT. COMPLICATIONS INCLUDE TAPE EXPOSURE (N=1), OBJECTIVE FAILURE TO CURE STRESS URINARY INCONTINENCE (N=11) AND SUBJECTIVE FAILURE TO CURE STRESS URINARY INCONTINENCE (N=13). IN CONCLUSION, THE CHANGE IN DISTANCE BETWEEN THE TAPE AND URETHRAL CAVITY LINE IN THE CENTER OF THE URETHRA IN THE MID-SAGITTAL PLANE AFTER STRAINING IS AN EFFECTIVE INDICATOR OF THE COMPRESSION EFFECT EXERTED BY THE SLING ON THE URETHRA AFTER A MID-URETHRAL SLING (MUS) PROCEDURE AND MAY CONTRIBUTE TO BOTH OBJECTIVE AND SUBJECTIVE CURE RATES POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079065 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female