BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE V-MESH GRAFT

    MDR report key: 3182203 · Received June 14, 2013

    Report

    Report Number
    1018233-2013-02436
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 9, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTO
    UDI-DI
    00801741016158
    PMA / PMN Number
    K101722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 ALYTE V-MESH GRAFT 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 OVERCORRECTION / TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATION 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 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).

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED HYPERTENSION, DIABETES, A LONG HISTORY OF UTEROVAGINAL PROLAPSE WITHOUT STRESS INCONTINENCE, INCISIONAL HERNIA, PELVIC ADHESIONS, COMPLETE PROCIDENTIA (COMPLETE UTEROVAGINAL PROLAPSE), RECURRENT PROLAPSE, VAGINAL VAULT PROLAPSE, APICAL CYSTOCELE, RECTOCELE, VOIDING DYSFUNCTION, DEFECATORY DYSFUNCTION, EVIDENCE OF EXTENSIVE ABDOMINAL AND PELVIC ADHESIONS, "EVIDENCE OF PREVIOUS RETROPERITONEAL MESH PLACEMENT WITH NO ATTACHMENT TO THE VAGINA OR THE SACRAL PROMONTORY," AND "WHAT APPEARED TO BE AN ACTIVE URINARY TRACT INFECTION," AND THE FOLLOWING PROCEDURES PELVIC EXAMINATION UNDER ANESTHESIA, EXPLORATORY LAPARATOMY, LYSIS OF ADHESIONS, TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, APPENDECTOMY, AND PROLENE MESH ABDOMINOSACRAL COLPOPEXY AND OBLITERATION OF POSTERIOR CUL-DE-SAC, AND INCISIONAL HERNIA REPAIR (OPERATIVE REPORT NO INCLUDED IN RECORDS PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272124 ALYTE V-MESH GRAFT No Match OTO C.R. BARD, INC. (COVINGTON) -1018233 NA HUWJ2002 00801741016158

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention