BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

    MDR report key: 3213785 · Received July 3, 2013

    Report

    Report Number
    1018233-2013-02712
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    October 31, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    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 REACTIONS: 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. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR BOWEL, WHICH MAY OCCUR DURING NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION AT THE IMPLANT SITE." (B)(4).

    Description of Event or Problem · 1

    (B)(4). THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PT'S OPERATING ROOM RECORD. ASSOCIATED MDRS: 1018233-2013-02713, 1018233-2013-02714, AND 1018233-2013-02715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303522 ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM ALIGN TO URETHRAL SUPPORT SYSTEM - HALO OTN C.R. BARD, INC. (COVINGTON) NA CVSA0022
    303626 ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM ALIGN TO URETHRAL SUPPORT SYSTEM - HALO OTN C.R. BARD, INC. (COVINGTON) NA CVSA0022

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR:| AVAULTA SOLO SYNTHETINC SUPPORT SYSTEM - ANTERIOR:| PROD # 486100| PROD # 486100, LOT # CVSC0011| PROD # 486100| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR:| PROD # 486100, LOT # CVSC0011| AVAULTA SOLO SYNTHETINC SUPPORT SYSTEM - ANTERIOR: