BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN R URETHRAL SUPPORT SYSTEM

    MDR report key: 3132730 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02074
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    March 14, 2016
    Manufacturer
    BARD SHANNON LIMITED.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218318 ALIGN R URETHRAL SUPPORT SYSTEM Mesh, surgical, polymeric FTL BARD SHANNON LIMITED. NA HUSD2609

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention