BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3123607 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-02066
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    October 3, 2016
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTN
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ALIGN TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, 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. PERFORATION OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-02067. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218758 ALIGN TO URETHRAL SUPPORT SYSTEM No Match OTN BARD SHANNON LIMITED NA HUTA2005
    218759 ALIGN TO URETHRAL SUPPORT SYSTEM No Match OTN BARD SHANNON LIMITED NA HUTA2005

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM| HALO NEEDLE| HALO NEEDLE| ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM