BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 3172349 · Received April 19, 2013

    Report

    Report Number
    1018233-2013-01325
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    November 27, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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 RECEIVED. ASSOCIATED MDR: 1018233-2013-01248.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171049 PELVITEX POLYPROPYLENE MESH Mesh, surgical, polymeric FTL C.R. BARD, INC. (COVINGTON) -1018233 NA PIC00480

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention ALIGN URETHRAL SUPPORT SYSTEM| AUTOSUTURE| AUTOSUTURE| ALIGN URETHRAL SUPPORT SYSTEM