BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN S URETHRAL SUPPORT SYSTEM

    MDR report key: 2850668 · Received November 20, 2012

    Report

    Report Number
    1018233-2012-01850
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BARD SHANNON LTD
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. 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: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN URETHRAL SUPPORT 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 OVERCORRECTION / TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN S URETHRAL SUPPORT SYSTEM FTL BARD SHANNON LTD NA HUTH0196

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention