BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3012131 · Received March 13, 2013

    Report

    Report Number
    1018233-2013-00819
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    October 9, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    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 LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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

    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 BLOOD LOSS, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, RECTAL PAIN, STRESS INCONTINENCE, MIXED URINARY INCONTINENCE, UNABLE TO VOID (URINARY RETENTION), VAGINAL BULGE, URINARY URGENCY, URINARY FREQUENCY, NOCTURIA (SLEEP DISTURBANCES), UNSPECIFIED URINARY PROBLEMS, VAGINAL DRYNESS, VAGINAL DISCOMFORT, SEXUAL DISCOMFORT, BLOOD IN URINE (HEMATURIA), PRESSURE IN VAGINA, CONSTIPATION, TENDERNESS, TIGHTNESS IN ABDOMEN, PELVIC MUSCLE SPASM, CYSTOCELE, RECTOCELE, VAGINAL PROLAPSE, PELVIC ORGAN PROLAPSE, VULVAR VESTIBULITIS (INFLAMMATION), WEIGHT GAIN (WEIGHT FLUX), WEAKNESS, NUMBNESS, TINGLING AND REQUIRED ADDITIONAL NONSURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINE LEAKAGE, VAGINAL PAIN AND LEUKOCYTES IN URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106700 ALIGN TO URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention RESTORELLE BY COLORPLAST