BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2010651 · Received February 24, 2011

    Report

    Report Number
    1213643-2011-00055
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 2, 2011
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR AN INFECTION. ALTHOUGH BOTH MESH DEVICES WERE EXPLANTED, IT WAS NOTED THAT THE INFECTION WAS ON THE SIDE OPPOSITE THE DAVOL FLAT MESH. 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." IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT THE INFECTION. IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE PROVIDED INFORMATION. WHILE INFECTION IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. A DHR REVIEW HAS BEEN CONDUCTED, INCLUDING STERILITY. NO MANUFACTURING ISSUES WERE IDENTIFIED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE.

    Description of Event or Problem · 1

    ON (B)(6) 2011: PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIA WITH INSERTION OF A DAVOL 3 X 6 MESH ON THE RIGHT AND ANOTHER MANUFACTURER'S MESH ON THE LEFT. PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2011: PATIENT WAS ADMITTED TO THE HOSPITAL WITH NECROTIZING FASCIITIS THAT HAS PREVIOUSLY BEEN DEBRIDED, INCREASING CELLULITIS - LEFT FLANK, AND WOUND VAC SPONGES REPLACED. ON (B)(6) 2011: PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH DEBRIDEMENT. GREENISH FLUID COMING OUT OF MIDDLE PORT SITE. GREENISH FOUL SMELLING FLUID NOTED ON LEFT SIDE OF ABDOMEN AND DISSECTED. THE TWO MESH WERE REMOVED. VAC SPONGES APPLIED TO LATERAL WOUND AND LOWER MIDLINE WOUND. PATIENT TREATED WITH IV ANTIBIOTICS. PATIENT'S CONDITION IMPROVED AND HE WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUJ0434

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R WOUND VAC THERAPY.