BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSIX LP W/ECHO

    MDR report key: 2629710 · Received June 20, 2012

    Report

    Report Number
    1213643-2012-00478
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K102766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING WAS RETURNED FOR EVAL AND NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. A REVIEW OF THE ETHICON SECURE STRAP'S INSTRUCTIONS FOR USE STATES: "APPROPRIATE FORCE SHOULD BE APPLIED TO THE DEVICE FOR APPLICATION OF STRAPS. EXCESSIVE FORCE MAY RESULT IN DAMAGE TO THE TISSUE, THE MATERIAL BEING FIXATED, OR THE DEVICE." IT APPEARS THAT THE REPORTED DAMAGE TO THE DAVOL MESH WAS LIKELY CAUSED BY FORCES APPLIED DURING USE, AND IS NOT DUE TO ANY DEFICIENCY. THE MESH WAS IMPLANTED IN THE PT, THEREFORE, NO EVAL CAN BE PERFORMED. IF ADD'L INFO IS PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A SALES REP: ON (B)(6) 2012 - THE SURGEON WAS PERFORMING A LAP VENTRAL HERNIA REPAIR WITH COMPOSIX L/P WITH ECHO. WHEN THE SURGEON WAS TACKING THE MESH, THE DOCTOR STARTED AT THE FAR RIM (NO POLYPRO) USING THE ETHICON SECURE STRAP FIXATION DEVICE, THE TACK WAS REPORTED TO HAVE GONE THROUGH THE MESH. THE SURGEON CONTINUED TO TACK AT THE SUTURE LINE, WITH MESH BEHIND IT AND THE TACK PULLED THROUGH. THE SECURE STRAP PUSHED THROUGH THE EPTFE SEVERAL OTHER TIMES DURING THE CASE. THE MESH WAS IMPLANTED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX LP W/ECHO FTL DAVOL INC NA HUVF1734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA