BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM

    MDR report key: 2230800 · Received August 23, 2011

    Report

    Report Number
    1018233-2011-00216
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    January 13, 2012
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AVAULTA SOLO SYNTHETIC SUPPORT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY 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, RECTUM, 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 VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE)."

    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 SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY AND HAS UNDERGONE CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA HUSI1691

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention URETEX TO| URETEX TO