BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    MDR report key: 2926162 · Received January 16, 2013

    Report

    Report Number
    1018233-2013-00098
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 18, 2012
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K031295
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: ¿THE PELVILACE BIOURETHRAL SUPPORT SYSTEM IS FOR SINGLE-PATIENT USE ONLY AND IS TO BE IMPLANTED SURGICALLY. DO NOT USE THE PELVILACE BIOURETHRAL SUPPORT SYSTEM IF THE INTEGRITY OF THE PACKAGING APPEARS COMPROMISED. THE PELVILACE BIOURETHRAL SUPPORT SYSTEM PELVICOL IMPLANT SHOULD BE HYDRATED OR MOIST WHEN THE PACKAGE IS OPENED. DEHYDRATED OR DRY TISSUE SHOULD NOT BE IMPLANTED. POSTOPERATIVE RETROPUBIC BLEEDING MAY OCCUR IN SOME PATIENTS AND MUST BE CONTROLLED PRIOR TO PATIENT RELEASE. THE PELVILACE BIOURETHRAL SUPPORT SYSTEM PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURE AND CARE TO AVOID PUNCTURE OF LARGE VESSELS NERVES, BLADDER, AND BOWEL, DURING NEEDLE PASSAGE. PROPER PLACEMENT OF THE PELVILACE BIOURETHRAL SUPPORT SYSTEM AT MID-URETHRA REQUIRES THAT THE TISSUE LIE FLAT WITH MINIMAL OR NO TENSION UNDER THE URETHRA. THE PELVILACE BIOURETHRAL SUPPORT SYSTEM IS INTENDED AS A SINGLE-USE, DISPOSABLE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THE PELVILACE BIOURETHRAL SUPPORT SYSTEM. PATIENTS SHOULD BE ADVISED THAT PREGNANCY FOLLOWING A PELVILACE BIOURETHRAL SUPPORT SYSTEM PROCEDURE MAY NEGATIVELY AFFECT THE SUCCESS OF THE PREVIOUS PROCEDURE AND INCONTINENCE MAY REOCCUR. THE SAFETY AND EFFECTIVENESS OF PELVILACE BIOURETHRAL SUPPORT SYSTEM HAS NOT BEEN ESTABLISHED FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN MALES AND CHILDREN UNDER THE AGE OF 18.¿ (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD¿L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24218 PELVILACE BIOURETHRAL SUPPORT SYSTEM FTL TISSUE SCIENCE LABORATORIES NA 03GO2015

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention