BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3060158 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01143
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BARD SHANNON LTD
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ALIGN TO URETHRAL SUPPORT 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. PERFORATION 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

    THIS MDR IS BEING FILED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PT'S ATTORNEY IN MDR 1018233-2013-01131. THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THE DEVICE IS LISTED IN THE PT'S OPERATIVE/PROCEDURAL PROGRESS NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154726 ALIGN TO URETHRAL SUPPORT SYSTEM FTL BARD SHANNON LTD NA HUUI0179

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH