BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO

    MDR report key: 3192029 · Received June 20, 2013

    Report

    Report Number
    1018233-2013-02478
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    December 19, 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
    GA, 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 REACTIONS: "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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02479, 1018233-2013-02480 AND 1018233-2013-02481.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FAILURE (FAILURE OF IMPLANT), DISCOMFORT, CONTINUED STRESS INCONTINENCE, PAIN, UNSPECIFIED URINARY PROBLEMS, BLEEDING AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED TRANSIENT POST-OPERATIVE HYPOTENSION DUE TO PATIENT CONTROLLED ANALGESIC PUMP, LEUKOCYTE ESTERASE IN URINE, BLOOD IN URINE (HEMATURIA), STRESS URINARY INCONTINENCE, OVERACTIVE BLADDER, CYSTOCELE/RECTOCELE (PROLAPSE), INTRINSIC SPHINCTER DYSFUNCTION, URINARY FREQUENCY, NOCTURIA, URINE LEAKAGE, GASTROINTESTINAL REFLUX DISEASE, PAIN, DISCOMFORT, NEED TO STRAIN TO COMPLETELY EMPTY BLADDER, PELVIC PAIN, TAUGHT/TENDER MESH ARMS BILATERALLY, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281937 ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO OTN BARD SHANNON LIMITED NA HUUA0192

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4), LOT # HUUA0194| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM POSTERIOR:| (B)(4)| LOT # 09B05-8| PELVISOFT ACELLULAR COLLAGEN BIOMESH: (B)(4),