BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR

    MDR report key: 3223474 · Received July 9, 2013

    Report

    Report Number
    1018233-2013-02775
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 12, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; 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 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM 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, REJECTION OF BIOLOGIC MATERIALS, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE)." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    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

    (B)(4). THE PT'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 URINARY RETENTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, EXPOSED MESH TREATED WITH VAGINAL ESTROGEN, URINARY URGENCY, PELVIC AND BUTTOCK PAIN, URINARY FREQUENCY, DYSMENORRHEA AND MESH EROSION REQUIRING SURGICAL EXCISION. THE PATIENT CONTINUED TO HAVE FURTHER MESH EXPOSURE AND UNDERWENT TWO ADDITIONAL IN-OFFICE MESH EXCISIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY RETENTION REQUIRING FOLEY CATHETER USAGE AT HOME, INFECTED MESH, PELVIC AND BUTTOCK PAIN WITH A BURNING AND TEARING SENSATION, YELLOW AND GREEN DISCHARGE, TENDERNESS AT THE APEX OF MESH NEAR THE RIGHT ISCHIAL SPINE AND MESH EROSION REQUIRING SURGICAL EXCISION ON (B)(6) 2008. THE PATIENT EXPERIENCED PAIN IN THE RECTAL AREA, CHRONIC CERVICITIS, CONSTIPATION, VAGINAL PAIN, BACK PAIN, PAIN WITH INSERTION OF TAMPONS, AND HAD REPAIR OF HER INTERNAL HEMORRHOIDS IN 2010. THE PATIENT EXPERIENCED DIFFICULTY URINATING FOR A BRIEF PERIOD, AN OVARIAN CYST, URINARY PRESSURE, ABDOMINAL PAIN, MINIMAL TENDERNESS TO THE MESH AND MESH ARMS SITES AND CANDIDA VULVOVAGINITIS. SHE OCCASIONALLY FELT A PULLING SENSATION WITH LIFTING OR STRENUOUS ACTIVITY NEAR THE ISCHIAL SPINE. SHE EXPERIENCED MENORRHAGIA, ABDOMINAL DISTENTION, ENDOMETRIAL ABLATION (2013), HUMAN PAPILLOMAVIRUS POSITIVE UPON PAPANICOLAOU SMEAR, COLPOSCOPIC BIOPSY, LOOP ELECTROSURGICAL EXCISION PROCEDURE (2014), STRESS URINARY INCONTINENCE, ARTHRITIS, DUODENAL ULCER, CHRONIC ANEMIA, INTESTINAL OPERATION IN 2008, RAYNAUD¿S DISEASE, CHOLECYSTECTOMY AND WOUND HEALING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312339 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR OTP C.R. BARD, INC. (COVINGTON) NA CVRH0102

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention