BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3D MAX MESH

    MDR report key: 2992868 · Received February 28, 2013

    Report

    Report Number
    1213643-2013-00073
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K081010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT¿S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVAL. THE MEDICAL RECORDS INDICATE THAT THE PATIENT WAS TREATED FOR INFLAMMATION AND INFECTION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS 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." THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2013-00072 FOR INFO RELATED TO THE PERFIX PLUG IMPLANTED ON (B)(6) 2007.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2007- PATIENT UNDERWENT REPAIR OF THE RIGHT INGUINAL HERNIA WITH IMPLANT OF BARD PERFIX PLUG. ON (B)(6) 2009: PATIENT UNDERWENT REPAIR OF A RECURRENT RIGHT INGUINAL HERNIA IMPLANTING THE PATIENT WITH BARD 3DMAX MESH. THE PATIENT'S ATTORNEY ALLEGES PAIN, ADD'L SURGERY, INFECTION INFLAMMATION, INJURY, DISABILITY, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86481 3D MAX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSI2239

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability