BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 2113523 · Received June 1, 2011

    Report

    Report Number
    1018233-2011-00114
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    November 10, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE IFU STATES IN THE ADVERSE EVENTS SECTION: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE DEVICE 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 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

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT(S) IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, HAS ENDURED IMPAIRED PHYSICAL RELATIONS WITH HER HUSBAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN TO URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. NA CVRI0044

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR