BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1973865 · Received January 19, 2011

    Report

    Report Number
    1213643-2011-00017
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    January 6, 2011
    Report Date
    December 21, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION. 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." THE INFO PROVIDED FURTHER STATES THAT THE PT DEVELOPED A FISTULA AS A RESULT OF THE INFECTION. PER DIGITAL PHOTOGRAPHS PROVIDED, THE PT UNDERWENT A BOWEL RESECTION, LIKELY AS TREATMENT OF THE FISTULA. HOWEVER, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WHILE INFECTION IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. AVAILABLE INFO INDICATES NO DEVICE WILL BE RETURNED AND/OR ADDITIONAL INFO WILL BE PROVIDED. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN ABDOMINAL MASS AROUND UMBILICAL AREA 40 YEARS PRIOR TO SURGERY WITH NO INFECTIOUS SYMPTOMS DETECTED BEFORE THE OPERATION. ON (B)(4) 2010 - UMBILICAL HERNIA REPAIR W/BARD COMPOSIX E/X MESH UTILIZING AN OPEN ANTERIOR APPROACH. THE MESH WAS FIXATED WITH NON-ABSORBABLE SUTURES. (B)(4) 2010 - PT PRESENTED WITH FEVER 12 DAYS POST OPERATION AND WAS DIAGNOSED WITH AN INCISIONAL INFECTION. MULTIPLE METHODS WERE USED TO ATTEMPT TO CONTROL AND TREAT THE INFECTION, BUT WITH NO EFFECT. THE INFECTION CAUSED A FISTULA AND PREVENTED INCISION TO HEAL. ON (B)(4) 2011 - MESH WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSI2335

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention