BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALILGN URETHRAL SUPPORT SYSTEM

    MDR report key: 2251611 · Received September 14, 2011

    Report

    Report Number
    1018233-2011-00253
    Event Type
    Injury
    Date Received
    September 14, 2011
    Report Date
    August 16, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATED IN THE ADVERSE REACTIONS SECTION: ¿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 OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, 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.¿ THE PRECAUTIONS SECTION STATES: ¿POSTOPERATIVE BLEEDING MAY OCCUR IN SOME PTS AND MUST BE CONTROLLED PRIOR TO PT RELEASE. THE IMPLANT PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURE AND CARE TO AVOID PUNCTURE OF LARGE VESSELS, NERVES, BLADDER, AND ANY VISCERA, DURING INTRODUCER NEEDLE PASSAGE. PROPER PLACEMENT OF THE MESH SLING IMPLANT AT MID-URETHRA REQUIRES THAT IT LIES FLAT WITH MINIMAL OR NOT TENSION UNDER THE URETHRA.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUFFERED SERIOUS BODILY INJURIES INCLUDING DYSPAREUNIA, HAS SEEN MULTIPLE PHYSICIANS AND HAS SUSTAINED PERMANENT INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention