BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11740464 · Received April 28, 2021

    Report

    Report Number
    2210968-2021-03948
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    June 20, 2019
    Report Date
    April 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON, INC. PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF SO, PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON, INC. PRODUCT USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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/S00192-019-04004-W PLEASE SEE ARTICLE ATTACHED. EVENTS RELATED TO TVT CAPTURED VIA 2210968-2021-03947.

    Description of Event or Problem · 1

    TITLE: ADJUSTABLE MINI-SLING COMPARED WITH CONVENTIONAL MID-URETHRAL SLINGS IN WOMEN WITH URINARY INCONTINENCE: A 3-YEAR FOLLOW-UP OF A RANDOMIZED CONTROLLED TRIAL THIS STUDY AIMED TO TO COMPARE THE LONG-TERM SUBJECTIVE OUTCOMES OF AN ADJUSTABLE SINGLEINCISIONSLING (AJUST®) VS STANDARD MID-URETHRAL SLINGS (SMUS) FOR THE TREATMENT OF WOMEN WITH STRESS URINARY INCONTINENCE. A TOTAL OF 205 WOMEN (N=107 IN THE ADJUST GROUP; N=98 IN SMUS GROUP) PARTICIPTED IN 3-YEAR FOLLOW-UP. AJUST® (BARD, MURRAY HILL, NJ, USA) WAS COMPARED WITH THE CONVENTIONAL MID-URETHRAL SLINGS (N=55) TENSION-FREE VAGINAL TAPE (TVT) (ETHICON, SOMERVILLE, NJ, USA) , (N=8) TVT-O INSIDE-OUT (ETHICON), AND (N=35) TRANS-OBTURATOR TAPE (TOT; MONARC; AMS, MINNEAPOLIS, MN, USA), DEPENDING ON THE TYPE OF THE SLING THAT EACH OF THE EIGHT CENTERS INSWEDEN, DENMARK, AND NORWAY PREFERRED TO USE. REPORTED COMPLICATIONS INCLUDED LEAKAGE (N=?), MICTURITIONS (PER DAY) (N=?), INCONTINENCE (N=?), DYSPAREUNIA (N=?) AND OVERACTIVE BLADDER (N=?). NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE GROUPS REGARDING SUBJECTIVE CURE RATE (50.9%VS 51.5%, P = 0.909) OR DYSPAREUNIA. BOTH GROUPS DEMONSTRATED SIMILAR POSTOPERATIVE PERCEPTION OF IMPROVEMENT IN ADDITION TO REDUCED URGENCY AND URGE URINARY INCONTINENCE. THE POSTOPERATIVE IMPROVEMENT REMAINED AT THE SAME LEVEL AFTER 3 YEARS AS IT WAS AT 1-YEAR FOLLOW-UP FOR BOTH AJUST® AND SMUS. IN CONCLUSION, AJUST® APPEARS TO BE EQUALLY EFFECTIVE AND SAFE AS SMUS WITH REGARD TO LONG-TERM FOLLOW-UP OF PATIENTREPORTED OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636989 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1