BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3101581 · Received May 3, 2013

    Report

    Report Number
    1018233-2013-01724
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    FTL
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SAMPLE WAS RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION FINDINGS, CURRENT MFG CONTROLS ARE CONSIDERED ADEQUATE AS TO DETECT AND SEGREGATE ANY NON-CONFORMING UNIT. EVENT DESCRIBED COULD NOT BE CONFIRMED AS A MFG RELATED ISSUE. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSES 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

    IT WAS REPORTED THAT THE PLASTIC PART FROM THE ANCILLARY BROKE. HOWEVER, THE DEVICE WAS STILL ABLE TO BE IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194382 AJUST ADJUSTABLE SINGLE INCISION SLING FTL BARD SHANNON LIMITED NA HUWF0535

    Patients

    Seq Age Sex Outcome Treatment
    1