BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3142689 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02198
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BARD SHANNON LTD
    Product Code
    FTL
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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, 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

    (B)(4). IT WAS REPORTED THAT THE CONSULTANT TRIED TO INSERT AN AJUST INTO THE PATIENT. THE ANCHOR SNAPPED IN HALF LEAVING HALF OF THE ANCHOR IN THE METAL INTRODUCER. HALF OF ONE OF THE ANCHORS WAS LEFT INSIDE THE PATIENT. A SECOND ATTEMPT WAS MADE WITH ANOTHER ADJUST FROM THE SAME BOX, BUT THE SAME THING HAPPENED. THE CONSULTANT EVENTUALLY INSERTED A 3RD AJUST (ALSO FROM THE SAME BOX) SUCCESSFULLY. ASSOCIATED MDR: 1018233-2013-02199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231236 AJUST ADJUSTABLE SINGLE INCISION SLING FTL BARD SHANNON LTD NA HUWH1795

    Patients

    Seq Age Sex Outcome Treatment
    1