BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN R URETHRAL SUPPORT SYSTEM

    MDR report key: 3080446 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01492
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    July 17, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    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

    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. PERFORATIONS 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).

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FREQUENCY, URGENCY, NOCTURIA, STRESS URINARY INCONTINENCE, URGE URINARY INCONTINENCE, CHRONIC PELVIC PAIN, DYSPAREUNIA, MULTIPLE URINARY TRACT INFECTIONS, LOWER URINARY TRACT SYMPTOMS, RENAL CORTICAL CYSTS, AND REQUIRED EXCISION OF MID URETHRAL SLING COMPLICATED BY A TEAR IN THE VAGINAL MUCOSA AND SMALL DEFECT IN THE URETHRA.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CLOT EVACUATION ON (B)(6) 2011, MICROHEMATURIA, PARTIAL MALROTATION OF THE RIGHT KIDNEY, SEVERAL SMALL LEFT RENAL CYSTS, VASCULAR CALCIFICATIONS, BILOBULATED FLUID COLLECTION IN THE LEFT PELVIS, ANTERIORLY TOUCHING THE ANTERIOR WALL OF THE BLADDER AND EXTENDING THROUGH A DEFECT IN THE ABDOMINAL WALL INTO THE SUBCUTANEOUS TISSUES, ABDOMINAL PAIN, BACK PAIN, URINARY RETENTION, WORSENING OF URINARY FREQUENCY AND URGENCY, MIXED INCONTINENCE, INCREASED BLADDER SENSITIVITY, SMALL BLADDER CAPACITY, DETRUSOR OVERACTIVITY, EPIGASTRIC PAIN, STRESS URINARY INCONTINENCE REQUIRING PADS FOR PROTECTION, SEVERELY REDUCED LIBIDO, NIGHTTIME URINARY INCONTINENCE, HESITANCY, DECREASED FORCE OF URINARY STREAM, SENSATION OF INCOMPLETE EMPTYING, DEPRESSION, ANXIETY, VAGINAL ATROPHY, GRADE ONE CYSTOCELE, EXTREME TENDERNESS ON PALPATION OF SLING AT BLADDER NECK, TIGHTNESS NOTED AT THE LEVEL OF THE SLING AND A COUPLE OF EPISODES OF LEAKAGE WITH URGENCY. SHE ALLEGED THAT SHE REQUIRED NONSURGICAL AND SURGICAL INTERVENTIONS INCLUDING ANTIBIOTICS, ANTICHOLINERGICS, HORMONE THERAPY, URODYNAMICS, AS WELL AS URETHROLYSIS AND EXCISION OF MID URETHRAL SLING ON (B)(6) 2014 WITH INTRAOPERATIVE SUTURE REPAIR OF SMALL TEAR IN THE MIDPORTION OF THE VAGINAL MUCOSA AND DEFECT IN THE URETHRA. SHE ALSO ALLEGED SHE EXPERIENCED VAGINAL MESH EROSION AND EXPOSURE, RECURRENCE OF VAGINAL PAIN, DIFFICULTY SITTING AND AN INFLAMED BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177201 ALIGN R URETHRAL SUPPORT SYSTEM OTN C.R. BARD, INC. (COVINGTON) -1018233 NA HUTF0302

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention