BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 10021639 · Received May 4, 2020

    Report

    Report Number
    2210968-2020-03706
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    April 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 05/04/2020. 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 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 ETHICON PRODUCTS (TVT ABBREVO) 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 PRODUCTS (TVT ABBREVO) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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/S00192-019-04159-6. (B)(4).

    Description of Event or Problem · 1

    TITLE: MID-URETHRAL SLING IN A DAY SURGERY SETTING: IS IT POSSIBLE? THE AIM OF THIS CASE¿CONTROL STUDY WAS TO COMPARE IMMEDIATE VERSUS DELAYED CATHETER REMOVAL FOLLOWING MID-URETHRAL SLING SURGERY, TO DETERMINE IF INDWELLING CATHETERISATION WAS NECESSARY AFTER THIS PROCEDURE. BETWEEN JANUARY 2014 AND DECEMBER 2018, 80 WOMEN (MEAN AGE=54 YEARS, AGE RANGE=41-69 YEARS; MEAN BMI=25.9 KG/M^2, BMI RANGE=22-30 KG/M^2) WERE UNDER IMMEDIATE CATHETER REMOVAL (ICR) AND 80 WOMEN (MEAN AGE=54.5 YEARS, AGE RANGE=41-68 YEARS; MEAN BMI=25.3 KG/M^2, BMI RANGE=23-28 KG/M^2) WERE UNDER DELAYED CATHETER REMOVAL (DCR). THESE PATIENTS UNDERWENT A TVT ABBREVO (ETHICON) FOR THE TREATMENT OF URODYNAMICALLY PROVEN STRESS INCONTINENCE (USI). REPORTED COMPLICATIONS INCLUDED VOIDING DYSFUNCTIONS (POST-VOID RESIDUAL >100 ML) (N=12) WHICH REQUIRED POSTOPERATIVE RE-CATHETERISATION IN 3 PATIENTS. ONE PATIENT IN ICR AND 2 PATIENTS IN DCR HAD IN/OUT RE-CATHETERISATIONS (TWICE FOR EVERY PATIENT), WITH A SUBSEQUENT INDWELLING CATHETER FOR 24H; POSTOPERATIVE URINARY TRACT INFECTION (N=10); EARLY ONSET OF OVERACTIVE BLADDER (OAB) AT 1 MONTH (N=6); LATE ONSET OF OAB AT 1 YEAR (N=12); VAGINAL EROSION (N=4). IN CONCLUSION, IMMEDIATE CATHETER REMOVAL ALLOWS THE PATIENT WITH URODYNAMICALLY PROVEN STRESS INCONTINENCE WITHOUT OAB SYMPTOMS, PROLAPSE AND VOIDING DYSFUNCTIONS, TO BE ADMITTED, TREATED AND DISCHARGED ON THE SAME DAY IN AN OUTPATIENT SETTING, WITH A HIGH SUBJECTIVE AND OBJECTIVE OUTCOMES AFTER AT LEAST A 1-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485188 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1