BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7362792 · Received March 22, 2018

    Report

    Report Number
    2210968-2018-71617
    Event Type
    Injury
    Date Received
    March 22, 2018
    Report Date
    September 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO FDA: 09/03/2019.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    TITLE: POSTOPERATIVE TRANSVAGINAL TAPE MOBILIZATION IN PREVENTING VOIDING DIFFICULTY AFTER TENSION-FREE VAGINAL TAPE PROCEDURES. AUTHOR(S): WEN-CHUN CHANG, BOR-CHING SHEU, SU-CHENG HUANG, MENG-TZUNG WU, WEN-CHIUNG HSU, LI-YUN CHOU, DAW-YUAN CHANG. CITATION: INT UROGYNECOL J (2010) 21:229¿233; DOI 10.1007/S00192-009-1016-5. THE RETROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY OF POSTOPERATIVE TRANSVAGINAL TAPE MOBILIZATION AS A METHOD OF TREATING URINARY RETENTION. DURING THE 52-MONTH PERIOD, 80 WOMEN (MEAN AGE SD 54±11 YEARS) WITH STRESS URINARY INCONTINENCE UNDERWENT TENSION-FREE VAGINAL TAPE PROCEDURE. IN ALL PATIENTS, A LOOP OF A 3-0 VICRYL SUTURE WAS MADE ALONG THE MIDPOINT OF THE TAPE WITH THE ENDS OF AT LEAST 3 CM FOR FURTHER MANIPULATION AND VAGINAL MUCOSA WAS CLOSED WITH INTERRUPTED SUTURES. FIVE PATIENTS HAD POSTOPERATIVE URINARY RETENTION AND WAS TREATED BY TRANSVAGINAL TAPE MOBILIZATION ON POSTOPERATIVE DAYS 1-3 WITHOUT COMPLICATIONS. THERE WERE ALSO 9 PATIENTS WHO COMPLAINED OF VOIDING DIFFICULTY (VOIDING WITH LITTLE STRAIN, POOR INTERRUPTED STREAM, OR FEELING OF RESIDUAL URINE AFTER VOIDING) AND WERE GIVEN CHOLINERGIC AGENTS SUCH AS BETHANECOL AND/OR DOXAZOCIN IN ADDITION TO SOME ANALGESICS. VOIDING SYMPTOMS WERE RESOLVED WITHIN 3 MONTHS IN 5 PATIENTS AND WERE DISCONTINUED IN ALL PATIENTS 6 TO 12 MONTHS POSTOPERATIVELY. POSTOPERATIVE URINARY RETENTION IS OFTEN RELATED TO THE AMOUNT OF TENSION PLACED ON THE SLING, IT WOULD BE MOST DESIRABLE TO USE LESS TENSION WITHOUT LEAVING THE PATIENT INCONTINENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205033 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1