BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3080429 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01241
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    March 25, 2013
    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
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. 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. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, 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 WOUND DEHISCENCE, INFLAMMATION OR EXTRUSION/EROSION OF 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 RECURRENCE OF INCONTINENCE." (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175791 AJUST ADJUSTABLE SINGLE INCISION SLING FTL C.R. BARD, INC. (COVINGTON) NA CVTD0020

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention