BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN URETHRAL SUPPORT SYSTEM

    MDR report key: 2041902 · Received March 30, 2011

    Report

    Report Number
    1018233-2011-00053
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    November 4, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CAN CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE CONSTRUCTIONS FOR USE PRESCRIBES THE PROPER METHOD OF PLACEMENT FOR THIS PRODUCT TO AVOID UNDUE INJURY TO THE PT AND DAMAGE TO THE PRODUCT. THE IFU STATES IN THE WARNING SECTION: "THE IMPLANT PROCEDURE AND THE INSTRUMENTATION ASSOCIATED WITH THE SURGICAL PLACEMENT OF THE SLING CARRY AN INHERENT RISK OR INFECTION AND BLEEDING, AS DO SIMILAR UROLOGICAL PROCEDURES." THE IFU ALSO STATES IN THE PRECAUTION SECTION: "POST-OPERATIVELY THE PT IS RECOMMENDED TO REFRAIN FROM HEAVY LIFTING AND/OR EXERCISE (I.E. CYCLING, JOGGING) FOR AT LEAST THREE TO FOUR WEEKS AND INTERCOURSE FOR ONE MONTH." ADDITIONALLY, IN THE ADVERSE EVENT SECTION, THE IFU STATES: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE SLING 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, AND TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFO, 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 MESH IMPLANTED, THE PT EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY AND PERMANENT AND SUBSTANTIAL DEFORMITY, AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. NA HUTH2003

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention AVAULTA PIUS ANTERIOR SYNTHETIC SUPPORT SYSTEM