BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3111245 · Received May 8, 2013

    Report

    Report Number
    1018233-2013-01629
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    November 3, 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
    NY, 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 OVERCORRECTION/TOO MUCH TENSION PLACED ON THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2013-01630 AND 1018233-2013-01631.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED POSTOPERATIVE FEVER, CHILLS, HEMOGLOBIN DECREASED POSTOPERATIVELY, FATIGUED, LOSS OF APPETITE, HIGH WHITE BLOOD CELL COUNT, LOW BLOOD PRESSURE, MILD ATHEROSCLEROTIC CHANGE, BLOODY VAGINAL DRAINAGE, EXPOSED MESH, FEELS MESH (FOREIGN BODY SENSATION), ANTERIOR MESH EROSION, EROSION OF THE VAGINAL MUCOSA, ERODED VAGINAL MESH IN THE POSTERIOR VAGINAL WALL ABUTTING THE CERVIX (FOREIGN BODY IN PATIENT), BLOOD LOSS, MESH FOLDED OVER ITSELF, BULGE FROM THE VAGINA, UTERINE PROLAPSE, PELVIC DISCOMFORT, DIFFICULTY WITH INTERCOURSE, URGENCY, INCOMPLETE EMPTYING OF BLADDER, CERVIX AT THE INTROITUS, EXTENDS BEYOND THE INTROITUS WITH VALSALVA, PROLAPSE, PALPABLE AND TENDER MESH, NABOTHIAN CYSTS, ATTENUATED PERINEUM, FAILURE OF MESH REPAIR (FAILURE OF IMPLANT), TENDERNESS AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202304 ALIGN TO URETHRAL SUPPORT SYSTEM OTN C.R. BARD, INC. (COVINGTON) NA CVRJ0021

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYS| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYS