BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD TEGRESS URETHRAL BULKING AGENT

    MDR report key: 2172016 · Received March 28, 2007

    Report

    Report Number
    1018233-2007-00021
    Event Type
    Injury
    Date Received
    March 28, 2007
    Date of Event
    January 2, 2007
    Report Date
    March 28, 2007
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE FORMS A COHESIVE, SPONGY MASS THAT SERVES TO BULK SURROUNDING TISSUE AND IS NOT SUBJECT TO ABSORPTION OR ENZYMATIC BREAKDOWN WITHIN THE BODY. THE LOW VISCOSITY OF THE IMPLANT SOLUTION AND THE COHESIVE MASS OF THE RESULTING IMPLANT REQUIRE SPECIFIC ATTENTION TO THE INJECTION SITE, NEEDLE ORIENTATION, DEPTH OF NEEDLE PLACEMENT, RATE OF INJECTION, AND INJECTION VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. DURING THE COURSE OF THE CLINICAL INVESTIGATION, 28 SUBJECTS RECEIVING THE URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. A PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OR FORCEPS TO FACILITATE HEALING. THE IFU INSTRUCTIONS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. CONTRAINDICATIONS INCLUDE PTS WITH THE FOLLOWING CONDITIONS: ACUTE CYSTITIS, URETHRITIS, OTHER ACUTE OR CHRONIC GENITOURINARY TRACT INFECTIONS, OR FRAGILE URETHRAL MUCOSAL LINING. (B)(4). BASELINE REPORT PREVIOUSLY PROVIDED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6) 2007, ADDITIONAL LOT# 43DPH003, 0.25 YRS.

    Description of Event or Problem · 1

    ADDITIONAL INFO FROM THE USER FACILITY REPORT: ON (B)(6) 2006, PT WAS ADMITTED FOR ELECTIVE SURGERY TO HAVE A TRANSURETHRAL IMPLANT OF TEGRESS MATERIAL. PT WAS SEEN AT SCHEDULED INTERVALS POST-OP. ON (B)(6) 2007 PT STILL COMPLAINED OF URGENCY AND STRESS INCONTINENCE. PT OFFERED SUBSEQUENT INJECTIONS OR OTHER ALTERNATIVES. PT SEEN ON (B)(6) 2007 AT WHICH TIME SHE COMPLAINED OF PAIN WITH INTERCOURSE, INCONTINENCE AND FEELING OF A BULGE IN HER URETHRA. CYSTOSCOPY WAS DONE AT THAT TIME WHICH REVEALED URETHRAL EROSION OF THE TEGRESS MATERIAL. PT HAD THE MATERIAL SURGICALLY REMOVED (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TEGRESS URETHRAL BULKING AGENT URETHRAL BULKING AGENT LNM C.R. BARD, INC. NA 43AQH002

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention