BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGRESS URETHRAL IMPLANT

    MDR report key: 3940393 · Received June 18, 2014

    Report

    Report Number
    1018233-2014-00155
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BARD PUERTO RICO
    Product Code
    FBK
    PMA / PMN Number
    K050688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED STRESS URINARY INCONTINENCE (SUI), UNSPECIFIED PAIN, UNSPECIFIED INFECTION, UNSPECIFIED BOWEL PROBLEMS, UNSPECIFIED RECURRENCE, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358105 TEGRESS URETHRAL IMPLANT FBK BARD PUERTO RICO NA 43KPH001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention