BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 16018426 · Received December 20, 2022

    Report

    Report Number
    2125050-2022-01418
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    April 26, 2022
    Report Date
    December 9, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05708932467407
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MELON J, KARJALAINEN PK, MCGANNON C, LEE JK, ROSAMILIA A. MEDIUM-TERM CLINICAL EFFICACY AND SAFETY OF SINGLE INCISION AND MODIFIED TRANS-OBTURATOR MID-URETHRAL SLINGS FOR FEMALE STRESS URINARY INCONTINENCE. GOCM 2 (2022) 57-62. HTTPS://DOI.ORG/10.1016/J.GOCM.2022.04.004. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, OF THE 60 WOMEN IMPLANTED WITH ALTIS BETWEEN 2012 AND 2018 WHO WERE AVAILABLE FOR FINAL ANALYSIS RELATED TO THIS STUDY: -TWO SLINGS WERE REMOVED OR "DIVIDED"; ONE WAS "DIVIDED" FIVE MONTHS POST OP FOR CHRONIC LOW-GRADE VOIDING DYSFUNCTION FOLLOWING EPISODIC CLEAN INTERMITTENT SELF-CATHETERIZATION. -ONE SLING WAS LOOSENED EARLY FOR VOIDING DYSFUNCTION. -TWO PATIENTS RECEIVED REPEATED SLINGS; ONE SLING HAD BEEN REMOVED A WEEK POST OP FOR SEVERE GROIN PAIN. A RETROPUBIC SLING WAS PLACED AT THAT TIME. -EARLY GROIN OR VAGINAL PAIN LASTING UP TO THREE MONTHS WAS REPORTED AS HIGHER IN THE ALTIS GROUP. IN THE SINGLE-INCISION-SLING GROUP, ALL PAIN WAS REPORTED AS RESOLVED BEFORE THREE MONTHS, EXCEPT FOR THREE ALTIS PATIENTS WHO REPORTED RESOLUTION AT 3, 6, AND 12 MONTHS RESPECTIVELY, WITH SIMPLE ANALGESIA AND PHYSIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447004 ALTIS SINGLE INCISION SLING SYSTEM SURGICAL MESH PAH COLOPLAST A/S 5196502400 05708932467407

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention