BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4202281 · Received October 15, 2014

    Report

    Report Number
    1213643-2014-00375
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PT INJURY AND MEDICAL RECORDS WERE LIMITED TO THE PT'S IMPLANT OPERATIVE REPORT AND PERI OPERATIVE IMPLANT RECORDS. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY. ON (B)(6) 2014, THE PT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH AND A NON BARD/DAVOL TVT DEVICE DURING AN ABDOMINAL SACROCOLPOPEXY AND CYSTOCELE REPAIR PROCEDURE, FOR THE TREATMENT OF VAGINAL VAULT PROLAPSE, ANTERIOR VAGINAL AND BLADDER PROLAPSE AND STRESS URINARY INCONTINENCE. OPERATIVE DICTATION INDICATES THE FLAT MESH WAS PLACED IN TWO SECTIONS WITH A PIECE PLACED POSTERIORLY, SUTURED WITH 5 ETHIBOND SUTURES AND A SMALLER PIECE PLACED ANTERIORLY, SUTURED WITH TWO PAIRS OF ETHIBOND SUTURES. THESE TWO PIECES WERE THEN FIXATED TOGETHER WITH AN ETHIBOND SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655366 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43GJD202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention