BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3853345 · Received May 27, 2014

    Report

    Report Number
    1213643-2014-00164
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 29, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, 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 HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PTS' ATTORNEY: (B)(6) 2007 - THE PT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTMY AND ABDOMINAL SACROCOLPOPEXY IN WHICH A BARD FLAT MESH WAS USED DUE TO A HISTORY OF UTERINE PROLAPSE AND RIGHT ABDOMINAL MASS. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311783 BARD FLAT MESH FTL DAVOL INC, SUB. C.R. BARD, INC. NA 43DPD008

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability