BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 16956449 · Received May 18, 2023

    Report

    Report Number
    2125050-2023-00597
    Event Type
    Injury
    Date Received
    May 18, 2023
    Report Date
    May 18, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. LOT NUMBER 2096801. PORTIONS OF THIS EVENT WERE PREVIOUSLY SUBMITTED VIA ALTERNATIVE SUMMARY REPORT (EXCEPTION NUMBER E201405) SUBMITTED BETWEEN AUGUST-SEPTEMBER 2016; THIS REPORT IS INTENDED TO BE A FOLLOW UP REPORT TO SUBMIT ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST; ALTHOUGH NOT VERIFIED. THE PATIENT'S LEGAL REPRESENTATIVE STATED THE PATIENT WAS EXPERIENCING VAGINAL SPOTTING AND RECURRENT URINARY TRACT INFECTIONS AND URINARY FREQUENCY. ON (B)(6) 2021 MESH EXPOSURE WAS OBSERVED. THE MESH WAS EXCISED UNDER GENERAL ANESTHESIA. ON (B)(6) 2022. RECURRENT STRESS URINARY INCONTINENCE WAS OBSERVED AND AN ALTIS SLING WAS PLACED UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380188 ARIS TRANSOBTURATOR KIT MESH OTN COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other