BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 9252461 · Received October 29, 2019

    Report

    Report Number
    2210968-2019-89202
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 1, 2018
    Report Date
    October 31, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 11/30/2020. CORRECTED INFORMATION: B3. 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. WAS THE 20-CM TVT TRANSOBTURATOR USED IN THE TRANSOBTURATOR GROUP AN ETHICON TVT-O PRODUCT? IF THE TVT-OBTURATOR IS AN ETHICON PRODUCT: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TVT-O) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (PERINEAL HEMATOMA, POSTOPERATIVE FEVER, UTI) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (TVT-O) INVOLVED? CORRECTED INFORMATION: B3.

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TENSION FREE VAGINAL TAPE ¿ ABBREVO) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (UTI/RECURRENT UTI) DESCRIBED IN THE ARTICLE? NO. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (TENSION FREE VAGINAL TAPE ¿ ABBREVO) INVOLVED? NO. I BELIEVE THAT UTI FOLLOWING MUS HAD NOTHING TO DO WITH THE PRODUCT. CITATION: INT J GYNECOL OBSTET (2018); 143: 333¿338. DOI: 10.1002/IJGO.12680. (B)(4).

    Description of Event or Problem · 1

    TITLE : PREVALENCE AND RISK FACTORS FOR URINARY TRACT INFECTION FOLLOWING STRESS URINARY INCONTINENCE SURGERY WITH TWO MIDURETHRAL SLING PROCEDURES THE AIM OF THE PRESENT STUDY WAS TO COMPARE PREVALENCE AND RISK FACTORS FOR UTI FOLLOWING MIDURETHRAL SLING SURGERY WITH EITHER THE ABBREVO PROCEDURE OR A STANDARD TRANSOBTURATOR PROCEDURE. THIS RETROSPECTIVE COHORT STUDY INVOLVES 178 FEMALE PATIENTS WHO UNDERWENT MIDURETHRAL SLING SURGERY TO TREAT STRESS URINARY INCONTINENCE BETWEEN JANUARY 1, 2014, AND AUGUST 11, 2015. OF 178 PATIENTS INCLUDED, 30 PATIENTS (MEAN AGE: 63.7±12.7 YEARS; MEAN BMI: 30.7 ± 15.2 KG/M2) UNDERWENT THE ABBREVO PROCEDURE USING GYNECARE ABBREVO CONTINENCE SYSTEM (ETHICON) AND 148 PATIENTS (61.4±12.2 YEARS; BMI: 28.1±4.5 KG/M2) UNDERWENT THE STANDARD TRANSOBTURATOR PROCEDURE. THE MESH WAS PLACED TRANSVAGINALLY VIA THE OBTURATOR FORAMEN (OBTURATOR AND ADDUCTOR MUSCLES) USING A HELICOIDAL-SPECIFIC DEVICE, AND EXPOSED THROUGH THE SKIN OF THE GROIN USING 2-MM INCISIONS. REPORTED COMPLICATION IN THE ABBREVO GROUP INCLUDED UTI/RECURRENT UTI (N-7) IN WHICH 4 PATIENTS RECEIVED ANTIBIOTIC TREATMENT. IN CONCLUSION, THE TWO PROCEDURES WERE COMPARABLE IN TERMS OF PREVALENCE AND RISK FACTORS FOR UTI DURING THE POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047309 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention