BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7945225 · Received October 8, 2018

    Report

    Report Number
    2210968-2018-76391
    Event Type
    Injury
    Date Received
    October 8, 2018
    Report Date
    September 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCTS 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 USED IN THIS PROCEDURE? CITATION: ACTA OBSTET GYNECOL SCAND 2017; 96:1347¿1356; DOI: 10.1111/AOGS.13205. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ADJUSTABLE MINI-SLING COMPARED WITH CONVENTIONAL MID-URETHRAL SLINGS IN WOMEN WITH URINARY INCONTINENCE. A RANDOMIZED CONTROLLED TRIAL". AUTHOR: MARTIN RUDNICKI , KATARINA VON BOTHMER-OSTLING2, ANJA HOLSTAD3, CLAES MAGNUSSON4, MEMONA MAJIDA5, CONSTANZE MERKEL6, JENS PRIEN7, ULF JAKOBSSON8 & PIA TELEMAN. CITATION: ACTA OBSTET GYNECOL SCAND 2017; 96:1347¿1356; DOI: 10.1111/AOGS.13205. THIS MULTICENTER PROSPECTIVE RANDOMIZED TRIAL AIMED TO COMPARE THE OBJECTIVE AND SUBJECTIVE OUTCOMES AND SHORT-TERM COMPLICATION RATES OF AN ADJUSTABLE SINGLE-INCISION MINI-SLING (SIMS) VS. STANDARD MID-URETHRAL SLINGS (SMUS) AND TO REPORT PAIN PERCEPTION AND COMPLICATIONS AT ONE-YEAR FOLLOW-UP. BETWEEN MAY2012 AND APR2014, 305 FEMALE PATIENTS WITH STRESS URINARY INCONTINENCE (SUI) UNDERWENT SURGERY USING EITHER SIMS (N=155; MEAN AGE SD OF 44.9 ± 6.9 YEARS) OR SMUS (N=150; MEAN AGE SD OF 46.1 ± 7.2 YEARS). IN SMUS GROUP, TVT, ETHICON (N=83) AND TVT-O INSIDE-OUT, ETHICON (N=130), TOT, MONARC (N=54) WERE USED. POSTOPERATIVE COMPLICATIONS IN SMUS GROUP INCLUDED BLADDER PERFORATION (N=3) FOR WHICH RECEIVED AN ADJUST SLING, URETHRAL LESION (N=1) FOR WHICH RECEIVED AN ADJUST SLING, BLEEDING >200ML (N=1), URINARY TRACT INFECTION (N=1), RETENTION (N=1) FOR WHICH TVT WAS CUT, POSTOPERATIVE DAY (POD) 1 PAIN (N=69%) AND POD6 PAIN (N=16%) TREATED WITH PARACETAMOL OR IBUPROFEN. AT 3-MONTH FOLLOW-UP IN SMUS GROUP, COMPLICATIONS INCLUDED SEVERE URGENCY (N=1) TREATED BY CUTTING THE SLING, URINARY TRACT INFECTION (N=7), FEVER (N=3), DELAYED EMPTYING (N=1), URGENCY INCONTINENCE (N=2), GROIN/ABDOMINAL PAIN (N=1), AND WOUND INFECTION (N=1). AT 1-YEAR FOLLOW-UP IN SMUS GROUP, COMPLICATIONS INCLUDED INCONTINENT EPISODES (N=11), URGE INCONTINENCE IN TVT (N=1) RECEIVED MEDICATION, NEW MESH EXPOSURE IN TVT (N=2) TREATED WITH RESECTION OF MESH, URINARY TRACT INFECTION (N=22), VOIDING DIFFICULTIES (N=10), AND DE NOVO DYSPAREUNIA (N=64). VAGINAL PERFORATION LATERALLY WAS DETECTED DURING THE SURGICAL PROCEDURE AND WAS MANAGED BEFORE THE SLING WAS PLACED. AJUST APPEARS TO BE AS EFFICIENT AS SMUS REGARDING OBJECTIVE AND SUBJECTIVE OUTCOMES AND WAS ASSOCIATED WITH LESS PAIN PERCEPTION DURING THE POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783209 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention