BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3951983 · Received July 15, 2014

    Report

    Report Number
    1213643-2014-00230
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    September 7, 2012
    Report Date
    June 18, 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 WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 DRAWN. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2014-00229 FOR INFORMATION RELATED TO THE OTHER BARD FLAT MESH IMPLANTED ON (B)(6) 2000.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED OFF A REVIEW OF THE PATIENT'S MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2000: THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY, RIGHT SALPINGO-OOPHORECTOMY WITH IMPLANTATION OF A BARD FLAT MESH (#1 AND #2). ON (B)(6) 2012, THE PATIENT UNDERWENT VISUALIZATION AND PARTIAL EXPLANT OF THE BARD FLAT MESH (#1 AND #2) DUE TO VAGINAL DISCHARGE AND CONCERN FOR INFECTION OF PELVIC MESH. OF NOTE, THERE WAS STILL MESH LEFT ATTACHED TO THE PATIENT'S SACRUM THAT COULD NOT BE REACHED SAFELY FROM A VAGINAL APPROACH. ON (B)(6) 2012, THE PATIENT UNDERWENT TOTAL EXPLANT OF THE BARD FLAT MESH DUE TO PERSISTENT PELVIC MESH INFECTION AND VAGINAL DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413115 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention