BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC

    MDR report key: 3152542 · Received June 5, 2013

    Report

    Report Number
    1018233-2013-02323
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    February 22, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    OTN
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EXTRUSION, PELVIC/VAGINAL PAIN, URINE LEAKAGE, SLING EROSION (EROSION), BLADDER OUTLET OBSTRUCTION (OBSTRUCTION), OVERACTIVE BLADDER/OVERFLOW, FRIABLE TISSUE/BLEED EASILY, TEAR AT OPENING OF URETHRA OF THE MUCOSA (MUCOSA DAMAGE), BLOOD LOSS, STRESS INCONTINENCE, URINARY FREQUENCY, PAIN, ELEVATED POST VOID RESIDUAL/URINARY RETENTION, URINARY TRACT INFECTIONS, ABDOMINAL PAIN, PELVIC PRESSURE, BACK PAIN, HEMATURIA, NOCTURIA, SLOW STREAM, URINARY STRAINING, CANNOT EMPTY, FATIGUE, URINARY INCONTINENCE, DEPRESSION, ANXIETY, INCOMPLETE BLADDER EMPTYING, VOIDING DYSFUNCTION, URGENCY (URINARY URGENCY), URINARY DRIBBLING, URINARY HESITANCY, DYSURIA, EXTREMITY EDEMA, HYPERTONICITY OF BLADDER, EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL (FOREIGN BODY IN PATIENT), LARGE CAPACITY BLADDER, TRABECULATIONS, INFLAMED TRIGONE (INFLAMMATION), ELEVATED BLADDER NECK, OVER TIGHTENED/KINKED SLING, RUFF AREA OF SLING EXPOSURE, WHEN SITS OR STANDS A CERTAIN WAY CAN FEEL BLADDER SLING (FOREIGN BODY SENSATION), HURTS WITH BOWEL MOVEMENT/VOID, ¿DOESN¿T FEEL RIGHT¿, THINKS SLING HAS MOVED, URINATING ALL THE TIME, LEUKOCYTES IN URINE, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249218 ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC OTN C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention