BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD TEGRESS

    MDR report key: 3192962 · Received August 23, 2006

    Report

    Report Number
    1018233-2006-00143
    Event Type
    Injury
    Date Received
    August 23, 2006
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LNM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PARTIAL SAMPLE WAS RETURNED FOR EVAL. THE SAMPLE CONSISTED OF A SMALL AMOUNT OF DESICCATED MATERIAL OF APPROXIMATELY 0.5 CM IN DIAMETER. AN FTIR SCAN OF THE MATERIAL WAS INCONCLUSIVE BECAUSE THE MATERIAL IS HEAVILY CONTAMINATED WITH BIOLOGICAL RESIDUE. THE SCAN DEMONSTRATED PEAKS CONSISTENT WITH THE BASE MATERIAL, POLY-VINYL ALCOHOL, BUT ALSO CONTAINED NUMEROUS OTHER PEAKS PARTICULARLY IN THE CARBANYL RANGE WHICH IS CONSISTENT WITH BIOLOGICAL MATERIAL. THE SCAN DID NOT REVEAL ANYTHING UNUSUAL OR IDENTIFY ANY KNOWN TOXIC SUBSTANCE. WE DO NOT ANTICIPATE ANY ISSUES WITH THE CYTOTOXICITY TESTING CURRENTLY UNDERWAY. DURING THE COURSE OF THE CLINICAL INVESTIGATION, 28 OUT OF 174 SUBJECTS RECEIVING TEGRESS URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED TEGRESS IMPLANT MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION TOO 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 INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF TEGRESS IMPLANT REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. THE LOW VISCOSITY OF THE TEGRESS 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 INJECTED VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. (B)(4).

    Description of Event or Problem · 1

    REF USER FACILITY REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TEGRESS URETHRAL IMPLANT LNM C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1