BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO

    MDR report key: 2963205 · Received February 12, 2013

    Report

    Report Number
    1018233-2013-00380
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 8, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTN
    UDI-DI
    00801741016226
    PMA / PMN Number
    K093747
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, 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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED 1018233-2013-00379.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61637 ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO OTN C.R. BARD, INC. (COVINGTON) -1018233 NA HUWB1088 00801741016226

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention "BARD FIXT SUTURING DEVICE SD105 HUW81088"| PELVISOFT ACELLULAR COLLAGEN BIOMESH| PELVISOFT ACELLULAR COLLAGEN BIOMESH