BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PLAT MESH

    MDR report key: 3940887 · Received July 8, 2014

    Report

    Report Number
    1213643-2014-00211
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 12, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    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 WERE LIMITED TO THE PATIENTS PERIOPERATIVE REPORT ONLY. 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) 1996 - THE PATIENT WAS IMPLANTED WITH A BARD FLAT MESH DURING A VAGINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, CULDOPLASTY AND POSTERIOR REPAIR PROCEDURE. THE ATTORNEY'S REPORT ALLEGES DISABILITY, PAIN, ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398442 BARD PLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 871670

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability