BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2861678 · Received December 4, 2012

    Report

    Report Number
    1213643-2012-00842
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 12, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. 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. THE PATIENT'S ATTORNEY ALLEGES INFECTION WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." A MANUFACTURING PREVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. 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) 2006 - THE PATIENT WAS IMPLANTED WITH MULTIPLE PELVIC MESH PRODUCTS INCLUDING BARD MESH. THE PATIENT'S ATTORNEY ALLEGES PAIN AND SUFFERING, PERMANENT INJURY, AND CHRONIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43LND018

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability