BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGRESS URETHRAL IMPLANT

    MDR report key: 4234452 · Received October 31, 2014

    Report

    Report Number
    1018233-2014-00292
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    October 2, 2014
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FBK
    PMA / PMN Number
    K050688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS EXPERIENCED ELEVATED POSTVOID RESIDUAL (90 MLS), RECURRENT STRESS URINARY INCONTINENCE (POSITIVE MARSHALL TEST), ADHESIONS BETWEEN ANTERIOR VAGINAL MUCOSA AND BLADDER, URINARY TRACT INFECTION, NOCTURIA, INTRINSIC SPHINCTERIC DEFICIENCY, "COAPTATION DIFFICULTY IN GETTING GOOD SUBMUCOSAL PURCHASE" IN THE AREAS THE PHYSICIAN ANTICIPATED WERE BOUND BY THE SLING, "FAIR AMOUNT OF PROLAPSE," UNSPECIFIED INFECTION, SIGNIFICANT SMOKER'S COUGH, HEMATURIA, EXTERNAL VAGINAL ITCHING, EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESION, VAGINAL ATROPHY WITH SCANT DISCHARGE, NODULAR BASAL CELL CARCINOMA OF VULVA, VULVAR IRRITATION/VULVITIS, ATROPHIC EXTERNAL GENITALIA, LEG PAIN (RELATED TO PERIPHERAL ARTERIAL DISEASE, CLAUDICATION, AND VENOUS INSUFFICIENCY) UNSPECIFIED PAIN, UNSPECIFIED EROSION, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED RECURRENCE, AND UNSPECIFIED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698476 TEGRESS URETHRAL IMPLANT FBK C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention