BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 3853346 · Received May 27, 2014

    Report

    Report Number
    1213643-2014-00158
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K110820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR LOCAL SALES REPRESENTATIVE MET WITH THE SURGEON TO GET ADDITIONAL INFORMATION. SURGEON REPORTED THAT INITIAL SURGERY WAS FINE AND THE PATIENT WENT HOME. SEVENTEEN DAYS LATER THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE AN ABSCESS WAS FOUND. A DRAIN WAS PLACED TO TRY AND DRAIN AWAY THE ABSCESS, WHEN THIS DIDN'T RESOLVE THE ISSUE THEY DECIDED TO REMOVE VIA SURGERY. DURING THE SURGERY THE SURGEON FOUND THAT THERE WAS AN INFECTION WAS ABOVE THE MESH IN ONE OF THE 10 LAYERS AND A BLOOD HEMATOMA WHICH WAS INFECTED. THE MESH, INFECTION AND HEMATOMA WERE REMOVED. AS THIS UNIT WAS PART OF A RECENT FIELD ACTION UNDERTAKEN BY DAVOL THE SALES REPRESENTATIVE DISCUSSED THIS WITH THE DOCTOR. THE FIELD ACTION WAS FOR A PACKAGING RELATED ISSUE. THE DOCTOR SAID THE OPERATING ROOM STAFF CAREFULLY INSPECTS THE PACKAGES BEFORE USE AND THEY WOULD HAVE SEEN IF THE INFLATION DEVICE PACKAGE WAS COMPROMISED PRIOR TO USE, AND IF THIS WAS THE CASE THEY WOULD NOT HAVE USED IN THE SURGERY. AS SUCH HE DID NOT FORESEE THAT THE INFLATION DEVICE OR MESH WOULD HAVE CAUSED THE INFECTION THAT WAS PRESENTED IN THE PATIENT SEVENTEEN (17) DAYS LATER. HEMATOMA AND INFECTION ARE BOTH 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". BASED ON THE CURRENTLY AVAILABLE INFORMATION WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT INFECTION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOLE: (B)(6) 2014 - A VENTRALIGHT ST W/ ECHO WAS USED TO TREAT AN INCISIONAL HERNIA. THE PATIENT DEVELOPED A POST-OPERATIVE ABSCESS. DRAINS PLACED BUT DID NOT RESOLVE. (B)(6) 2014 - PATIENT UNDERWENT EXPLANT OF THE MESH AND AN INFECTED HEMATOMA. THE INFECTION WAS NOTED TO BE ABOVE THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311771 VENTRALIGHT ST W/ ECHO FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXL0495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention