BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISIONS SLING

    MDR report key: 2831192 · Received November 6, 2012

    Report

    Report Number
    1018233-2012-01700
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE FINISHED PRODUCT MET ALL SPECS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. 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 AJUST SLING SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, ABSCESS OR FISTULA FORMATION 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. PERFORATION OR LACERATION OF VESSELS, NERVES, BLADDER, URETHRA, OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER PASSAGE. IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EXTRUSION/EROSION AT THE IMPLANT. KNOWN RISKS OF ALL SURGICAL PROCEDURES FOR THE TREATMENT OF INCONTINENCE, WHICH MAY INCLUDE PAIN, DEVICE MIGRATION, AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENT OF INCONTINENCE." (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 PAIN, DISABILITY AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AJUST ADJUSTABLE SINGLE INCISIONS SLING FTL C.R. BARD, INC. (COVINGTON) NA CVSJX056R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention