BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGRESS URETHRAL IMPLANT

    MDR report key: 3213787 · Received July 3, 2013

    Report

    Report Number
    1018233-2013-02727
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LNM
    PMA / PMN Number
    P030030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP SUPPLEMENTAL REPORT WILL BE MAILED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304878 TEGRESS URETHRAL IMPLANT LNM C.R. BARD, INC. NA 0602A061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention URETEX TO2 URETHRAL SUPPORT SYSTEM| PROD # 485054, LOT NUMBER: SFG0020| PELVITEX POLYPROPYLENE MESH| PROD # 486015, LOT NUMBER: PFA00373