BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 5720732 · Received June 13, 2016

    Report

    Report Number
    1213643-2016-00255
    Event Type
    Injury
    Date Received
    June 13, 2016
    Report Date
    May 24, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED TO DATE, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS REPORTED. THE PATIENT HAS NOT PROVIDED DAVOL WITH A LOT NUMBER; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. SEROMA AND INFECTION ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARMING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." AT THIS TIME THE PATIENT THE PATIENT IS UNWILLING TO PROVIDE ANY OF THE ADDITIONAL INFORMATION THAT WAS REQUESTED BY DAVOL FIELD ASSURANCE. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT: PATIENT UNDERWENT REPAIR OF A SMALL UMBILICAL HERNIA USING A BARD/DAVOL VENTRALIGHT ST HERNIA PATCH. WITHIN 3 HOURS POSTOPERATIVELY THE PATIENT DEVELOPED A FEVER OF 103 DEGREES. PATIENT REPORTS HE WAS THEN TREATED WITH AN ANTIBIOTIC HE IS ALLERGIC TO AND THE FEVER CONTINUED. AFTER CHANGING ANTIBIOTICS THE FEVER WAS CONTROLLED AND THE PATIENT WENT HOME. PATIENT UNDERWENT AN MRI WHICH REVEALED AN INFECTED FLUID POCKET ON "TOP OF THE MESH" (SEPRA SIDE) AND OPINION THAT IT WAS INCORPORATED INTO THE ABDOMINAL WALL. THREE WEEKS POST IMPLANT, THE PATIENT WAS TAKEN BACK TO THE OR AND THE MESH WAS REMOVED. PATIENT ALLEGES THE MESH INCORPORATED INTO THE ABDOMINAL WALL AS INTENDED; HOWEVER, WHEN REMOVED THE SURGEON ALSO REMOVED ALL OF THE ABDOMINAL MUSCLES ALONG WITH IT. PATIENT ALSO ALLEGES HE IS NOW FULLY DISABLED DUE TO HAVING ALL OF THE ABDOMINAL MUSCLES REMOVED FROM HIS ABDOMEN. HE DID NOT ALLEGE THAT THE MESH CAUSED THE PROBLEM, BUT FELT THE DOCTOR SHOULD HAVE TAKEN IT OUT MUCH SOONER THAN HE DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375422 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S