BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 2934354 · Received January 28, 2013

    Report

    Report Number
    1018233-2013-00177
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    February 23, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    PAH
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS 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, 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 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 PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37834 AJUST ADJUSTABLE SINGLE INCISION SLING PAH C.R. BARD, INC. (COVINGTON) NA CVTAX023R
    37835 AJUST ADJUSTABLE SINGLE INCISION SLING PAH C.R. BARD, INC. (COVINGTON) NA CVTAX023R

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention UNKNOWN INTERCEED