BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3132735 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02073
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    November 20, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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.

    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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL MESH EROSION WITH EXCISION/REMOVAL, RECTOCELE, ENTEROCELE, POSTERIOR COLPORRHAPHY WITH ENTEROCELE REPAIR, PLACEMENT OF MESH, CHRONIC SMALL BOWEL OBSTRUCTION, PELVIC ABSCESS, CHRONIC SMALL BOWEL PERFORATION, LAPAROSCOPIC LYSIS OF ADHESIONS WITH SMALL BOWEL RESECTION X2, SIGMOIDOSCOPY, CHRONIC STRICTURE SECONDARY TO ACUTE DIVERTICULITIS, INFECTIOUS/INFLAMMATORY COLITIS, CONSTIPATION, MODERATE BILIARY DUCTAL DILATION, HYPERVASCULAR LESIONS WITHIN THE DOME OF THE RIGHT HEPATIC LOBE, MILD INTRAHEPATIC BILIARY DILATATION, DRAINAGE OF PELVIC ABSCESS, HIATAL HERNIA, CT FINDINGS SUGGESTIVE OF SIGMOID COLON MALIGNANCY, GASTROENTERITIS, EXTENSIVE VASCULAR CALCIFICATION, CYSTOCELE, FREQUENCY AND URGENCY OF URINATION, SUPRAPUBIC PRESSURE, SLING EROSION, OVERACTIVE BLADDER, URGE INCONTINENCE, ABDOMINAL PAIN, DIARRHEA, URINARY TRACT INFECTION, SEPSIS, LEFT MAINSTREAM BRONCHUS MASS, ISCHEMIC STROKE, PLEURAL EFFUSION, FEMUR FRACTURE, AND PNEUMONIA.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL DISCHARGE, STRESS URINARY INCONTINENCE, LEAKAGE, BULGING IN THE RECTUM THROUGH THE INTROITUS, STRAINING WITH BOWEL MOVEMENTS, REQUIRED NONSURGICAL AND SURGICAL INTERVENTIONS SUCH AS URINARY ANTISPASMODICS, ANTIBIOTICS AND COLONOSCOPY.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PELVIC ORGAN PROLAPSE, PAIN, VAGINAL PAIN, DYSPAREUNIA, ANXIETY, NAUSEA, VOMITING, WEAKNESS, FATIGUE, MESH COMPLICATIONS, FAILURE OF IMPLANT, FOREIGN BODY IN PATIENT, PERFORATION OF ORGAN, LIMITED ACTIVATES, LOSS OF SEXUAL RELATIONSHIP, HYPOTENSION, PERITONITIS, BLADDER AND VAGINAL INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218508 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR FTL C.R. BARD, INC. (COVINGTON) NA HUTC2306

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention