BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJUST ADJUSTABLE SGL INCISION SLING

    MDR report key: 2993885 · Received March 1, 2013

    Report

    Report Number
    1018233-2013-00658
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    December 29, 2016
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    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 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY FREQUENCY, URGENCY, PELVIC PAIN, ADHESIONS, SCAR (SCARRING), CYSTOTOMY (ORGAN PERFORATION), AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89840 ADJUST ADJUSTABLE SGL INCISION SLING PAH C.R. BARD, INC. (COVINGTON) NA CVTCX024

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention