BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3111244 · Received May 8, 2013

    Report

    Report Number
    1018233-2013-01631
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    November 3, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    OTP
    PMA / PMN Number
    K082571
    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 INSTRUCTION FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES BLADDER, BOWEL, RECTUM OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." (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: 1018233-2013-01629 AND 1018233-2013-01630.

    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
    202277 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR OTP C.R. BARD, INC. (COVINGTON) NA CVRJ0023

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYS| ALIGN TO URETHRAL SUPPORT SYSTEM