BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 2912929 · Received January 9, 2013

    Report

    Report Number
    1018233-2013-00044
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    February 2, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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 TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH 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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED RECURRENT STRESS INCONTINENCE REQUIRING PLACEMENT OF A SECOND PUBOVAGINAL SLING. ASSOCIATED MDR: 1018233-2013-00061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13231 ALIGN TO URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention