BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD TEGRESS

    MDR report key: 3193011 · Received August 25, 2006

    Report

    Report Number
    3193011
    Event Type
    Injury
    Date Received
    August 25, 2006
    Date of Event
    July 10, 2006
    Report Date
    July 17, 2006
    Manufacturer
    BARD UROLOGICAL
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR TEGRESS IMPLANT. THE PT HAD A PREVIOUS IMPLANT PERFORMED ON (B)(6) 2006. WHEN THE SURGEON ATTEMPTED IMPLANT, HE NOTED VISABLE TEGRESS MATERIAL WITHOUT OVERLYING URETHRAL MUCOSA FROM PREVIOUS IMPLANT. THE MATERIAL WAS REMOVED AND THE PT HAD TO BE RESCHEDULED FOR ADDITIONAL IMPLANT AT A LATER DATE. REF MFR REPORT # 1018233-2006-00143.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TEGRESS URETHRAL IMPLANT FBK BARD UROLOGICAL 43KHP002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention