BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3854867 · Received May 21, 2014

    Report

    Report Number
    1213643-2014-00149
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 13, 2008
    Report Date
    April 24, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A PATIENT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORD COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. 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 PATIENT'S ATTORNEY: ON (B)(6) 2007 - THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL "MARLEX" MESH DURING A CYSTOCELE REPAIR. ON(B)(6) 2008 - THE PATIENT UNDERWENT IMPLANT OF A NON BARD SLING AND EXPLANT OF THE BARD/DAVOL "MARLEX" MESH DUE TO SUI AND ERODED ANTERIOR CYSTOCELE MESH. POST EXPLANT, THE PATIENT CONTINUED TO HAVE ISSUES REGARDING NON BARD MESH. ON (B)(6) 2012 - THE PATIENT AGAIN UNDERWENT A EXCISION OF THE NON BARD/DAVOL MESH DURING A PARAVAGINAL REPAIR AND IMPLANT OF ADDITIONAL IMPLANTS OF ANTERIOR AND POSTERIOR NON BARD/DAVOL MESH. THE ATTORNEY'S REPORT ALLEGES PAIN AND SUFFERING, PERMANENT INJURY, ADDITIONAL MEDICAL TREATMENT AND DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303937 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S