BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVILACE TO BIOURETHRAL SUPPORT SYSTEM

    MDR report key: 3060153 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01136
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K042949
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ADVERSE EVENTS: "POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE PELVILACE TO SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR BOWEL, WHICH MAY OCCUR DURING NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION AT THE IMPLANT SITE." (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-01137 AND 1018233-2013-001138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155484 PELVILACE TO BIOURETHRAL SUPPORT SYSTEM FTL TISSUE SCIENCE LABORATORIES NA CVSD0006

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH X2| INTERCEED ADHESION BARRIER