BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR SLING (COLOPLAST)

    MDR report key: 12392928 · Received August 31, 2021

    Report

    Report Number
    2125050-2021-01224
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    August 10, 2012
    Report Date
    January 29, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442954
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED. COLOPLAST ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION. H6: E020201 AND E2306 REMOVED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS IDENTIFIED IN THE RISK MANAGEMENT DOCUMENTATION EXCLUDING ANXIETY, AMBULATORY DIFFICULTIES, AND DECREASED APPETITE. THERE ARE NO CLINICAL STUDIES OR LITERATURE TO SUPPORT A SPECIFIC CAUSAL RELATIONSHIP BETWEEN ARIS AND ANXIETY, AMBULATORY DIFFICULTIES, AND DECREASED APPETITE. COMPLAINTS ARE REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED TO COLOPLAST, THOUGH NOT VERIFIED. THE PATIENT PRESENTED WITH STRESS URINARY INCONTINENCE PRIOR TO ARIS PLACEMENT. POST ARIS REMOVAL, FOLLOW-UP SHOWED PERSISTENT BUT LESS INTENSE PAIN AND RECURRENCE OF STRESS INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT: AK090058. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT EXPERIENCED THE FOLLOWING: RADIATING AND PERSISTENT PAIN, A FEELING OF THE SLING LOWERING OR FALLING, FEELING AS THOUGH THE SLING IS TOO LONG ON THE RIGHT SIDE, SCIATIC PAIN RELATED TO TOT, DIFFICULTY WALKING AND SITTING DUE TO PAIN, BLADDER DISCOMFORT, URINARY FREQUENCY AND URGENCY, NOCTURIA, DYSPAREUNIA, ANXIETY, INSOMNIA, RESTLESSNESS, DECREASED APPETITE, AND MUSCULAR TENSION. AN MRI CONDUCTED ON (B)(6) 2019 NOTED TEARS AND MINOR DEGRADATIVE CHANGES TO THE RIGHT AND LEFT SACRO-ILIAC JOINTS. ON (B)(6) 2019, THE DEVICE WAS REMOVED WITH EXPLORATION OF THE OBTURATOR SPACE, URETHRAL LYSIS, VAGINAL PARAVAGINAL, DISSECTION AND MESH REMOVAL FROM THE DEEP OBTURATOR INTERNUS EXTERNUS AND ADDUCTOR MUSCLES, AND ANTERIOR COLPORRHAPHY UNDER GENERAL ANESTHESIA. THE FINAL REPORT FOR THAT PROCEDURE NOTED FIBROSIS AND PATCHY MILD CHRONIC INFLAMMATION, WHITISH/YELLOW DISCHARGE, AND CYSTITIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED URINARY INCONTINENCE, NEW RIGHT SIDED PAIN SINCE THE SLING WAS REMOVED, PAIN WITH URINATION, URGENCY, AND STRESS INCONTINENCE. UA AND URINE CULTURE TESTED POSITIVE FOR 3 TYPES OF BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296111 ARIS TRANSOBTURATOR SLING (COLOPLAST) FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER OTN COLOPLAST A/S 5195512400 AK090058_5195102400 05708932442954

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R