BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2943731 · Received January 29, 2013

    Report

    Report Number
    1213643-2013-00034
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 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
    IA, 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 PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. 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 BY THE PT'S ATTORNEY: ON (B)(6) 2007 - PT WAS IMPLANTED WITH MULTIPLE PELVIC DEVICES INCLUDING A FLAT MESH. ATTORNEY'S REPORT ALLEGED 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
    38469 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURG0889

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability