BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 12433942 · Received September 7, 2021

    Report

    Report Number
    2125050-2021-01266
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    December 14, 2014
    Report Date
    September 7, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442961
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BECAUSE EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. A REVIEW OF THE DEVICE HISTORY RECORD BY THE CONTRACT MANUFACTURER CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT. LOT AK090058. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION THE ARIS WAS IMPLANTED ON (B)(6) 2012 AND THERE WAS A REPORT OF PAIN AND URINARY TRACT INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331018 ARIS TRANSOBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195512400 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention