BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3231596 · Received July 12, 2013

    Report

    Report Number
    1213643-2013-00307
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 22, 2009
    Report Date
    July 1, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE AT THIS POINT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PATIENT'S MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2003 - THE PATIENT WAS IMPLANTED WITH AN UNKNOWN BARD MARLEX MESH DURING A VAGINAL COLPORRHAPHY PROCEDURE. (B)(6) 2009 - THE PATIENT UNDERWENT RESECTION OF THE PREVIOUSLY PLACED VAGINAL MESH DUE TO THE MESH ERODING THROUGH THE VAGINA AND PARTIAL EXPLANT OF MESH MATERIAL. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, EROSION, NERVE DAMAGE, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321484 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability