BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN R URETHRAL SUPPORT SYSTEM

    MDR report key: 2230501 · Received August 12, 2011

    Report

    Report Number
    1018233-2011-00190
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    February 25, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENSION, 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." THE PRECAUTIONS SECTION STATES: "PROPER PLACEMENT OF THE MESH SLING IMPLANT AT MID-URETHRA REQUIRES THAT IT LIES FLAT WITH MINIMAL OR NO TENSION UNDER THE URETHRA." (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT (S) IMPLANTED, THE PT HAS EXPERIENCED MULTIPLE COMPLICATIONS INCLUDING EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, LOSS OF PROPER BLADDER FUNCTIONING, AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED POSTOPERATIVE URINARY RETENTION REQUIRING INTERMITTENT SELF-CATHETERIZATION, RECURRENT URINARY TRACT INFECTIONS, RECURRENT URINARY INCONTINENCE, RECURRENT RECTOCELE· AND CYSTOCELE, VAGINAL ENTEROCELE, DYSPAREUNIA (REPORTEDLY REQUIRED ANTERIOR MESH EXCISION DUE TO DYSPAREUNIA), DYSURIA, PELVIC PAIN, VAGINAL PROLAPSE, ABDOMINAL PAIN, CONSTIPATION, VAGINAL DISCHARGE, INSOMNIA, ANXIETY AND DEPRESSION.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED: VAGINAL PAIN, INFECTION, INFLAMMATION, EROSION, NEUROPATHIC PAIN, FORMATION OF SCAR TISSUE, INABILITY TO CONFIDENTLY AND PLEASURABLY HAVE INTERCOURSE, DIFFICULTY EMPTYING THE BLADDER, AND LOSS OF CONSORTIUM.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY RETENTION, INABILITY TO VOID, URINARY INCONTINENCE, LEAKAGE, SELF-INTERMITTENT CATHETERIZATION, RIGHT FLANK PAIN, RECURRENT URINARY TRACT INFECTIONS, BILATERAL NONOBSTRUCTING TINY RENAL CALCULI, CALCIFICATION IN DISTAL URETERS, LOW URINE VOLUME SUPERSATURATED WITH CALCIUM, OXALATE, AND URIC ACID, PELVIC PAIN, ADNEXAL CYST, PERSISTENT MICROSCOPIC HEMATURIA, SIGNIFICANT PROLAPSE OF POSTERIOR VAGINAL WALL, CONSTIPATION, DYSPAREUNIA, PRESSURE SENSATION, RECURRENT RECTOCELE, LOSS OF LATERAL VAGINAL SUPPORTS, DIARRHEA, INCOMPLETE BLADDER EMPTYING, VAGINAL DISCHARGE, MINFOLD AT PROXIMAL AVAULTA BUT NO EROSION, MILD PAIN WITH DIRECT PRESSURE ON PROXIMAL RIGHT ARM OF AVAULTA, DYSURIA, RECURRENT CYSTOCELE, NOCTURIA, URINARY STREAM SLOWING, URINARY FREQUENCY, VAGINITIS AND VULVOVAGINITIS, VAGINAL ENTEROCELE, BAND OF AVAULTA TISSUE AT BLADDER NECK, URINE ODOR, URINARY URGENCY, REMOVAL OF ANTERIOR MESH (X2), BURNING, PULLING PAIN, LEG PAIN, PELVIC PAIN THAT GOES DOWN OUTER THIGHS, PELVIC FLOOR DYSFUNCTION, PHYSICAL THERAPY TREATMENTS, TRIGGER POINT INJECTIONS, MESH RIDGING WITH SIGNIFICANT TENDERNESS ON PALPATION, REMOVAL OF SIGNIFICANT SCAR TISSUE, MYALGIAS, RECTAL MUSCLE SPASM, TRANSVAGINAL BOTOX INJECTION, MESH EROSION, AND REQUIRED SURGICAL AND NONSURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN R URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. (COVINGTON) -1018233 NA HUSK0700

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention