BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN URETHRAL SUPPORT SYSTEM

    MDR report key: 2092892 · Received May 11, 2011

    Report

    Report Number
    1018233-2011-00103
    Event Type
    Injury
    Date Received
    May 11, 2011
    Report Date
    December 28, 2015
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN THEREFORE NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE PRESCRIBES THE PROPER METHOD OF PLACEMENT FOR THIS PRODUCT TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. THE IFU STATES IN THE ADVERSE EVENT SECTION: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE SLING MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS, FISTULA FORMATION OR SCARRING 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 WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH THE VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF INCONTINENCE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, INCLUDING EXTREME PAIN, INFECTION AND EROSION OF HER INTERNAL BODILY TISSUES, HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES, AND SHE SUSTAINED PERMANENT INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM POSTERIOR