BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 5351546 · Received January 7, 2016

    Report

    Report Number
    1213643-2016-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 18, 2015
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED THE SURGEON USED A 10MM TROCAR. A REVIEW OF THE IFU FOR VENTRALIGHT ST MESH SHOWS THAT A 12 MM TROCAR IS THE RECOMMENDED SIZE FOR PRODUCT CODE 5954810. IT IS ALSO REPORTED THAT MESH MAY NOT HAVE BEEN PROPERLY HYDRATED. REGARDING HYDRATION THE IFU STATES, "IT IS RECOMMENDED THAT VENTRALIGHT ST MESH BE COMPLETELY IMMERSED IN STERILE SALINE FOR NO MORE THAN 1-3 SECONDS IMMEDIATELY PRIOR TO PLACEMENT IN ORDER TO MAXIMIZE THE FLEXIBILITY OF THE PROSTHESIS." AN IN-SERVICE HAS BEEN SCHEDULED, AND WILL BE CONDUCTED BY A DAVOL REPRESENTATIVE WITH THE OR STAFF REGARDING PROPER PREPARATION AND HYDRATION OF THE VENTRALIGHT ST MESH. WITHOUT HAVING THE SAMPLE FOR EVALUATION, AT THIS TIME NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, IT HAS BEEN REPORTED THAT THE SAMPLE IS BEING RETURNED TO DAVOL FOR EVALUATION. WHEN/IF THE SAMPLE IS RETURNED AND HAS BEEN EVALUATED A SUPPLEMENTAL MDR WILL BE SUBMITTED TO DOCUMENT OUR FINDINGS. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR AS THE SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EXAMINED AND AREAS OF DELAMINATION WERE FOUND ON THE ST (HYDROGEL) SIDE. EXAMINATION OF THE MESH FOUND NO ANOMALIES. AS REPORTED THE PROBLEM APPEARS TO HAVE BEEN DUE TO THE PREPARATION OF THE DEVICE BY THE USER. AN IN-SERVICE WITH THE OPERATING ROOM STAFF REGARDING PROPER PREPARATION AND HYDRATION OF THE VENTRALIGHT ST MESH HAS BEEN COMPLETED. ADDITIONALLY, A BARD/DAVOL REPRESENTATIVE HAS MET WITH THE SURGEON TO DISCUSS THE PROBLEM. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. PATIENT INFORMATION HAS NOT BEEN PROVIDED DUE TO THE CONFIDENTIALITY LAWS OF (B)(6), AS THE HOSPITAL IS NOT PERMITTED TO RELEASE ANY TYPE OF PATIENT IDENTIFYING INFORMATION WITHOUT A LEGAL ORDER REQUESTING INFORMATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: IT WAS REPORTED THAT AFTER THE SURGEON HAD PLACED THE VENTRALIGHT ST HERNIA PATCH THROUGH A 10MM TROCAR HE STATED THAT THE MESH APPEARED TO BE DELAMINATING AND THE SEPRAFILM WAS PULLING AWAY FROM THE POLYPROPYLENE MESH. THE CONTACT REPORTED THAT IT WAS LIKELY THAT THE MESH WAS NOT HYDRATED PROPERLY PRIOR TO USE. THE PATCH WAS REMOVED WITHOUT ISSUE AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10917 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. HUZG0184

    Patients

    Seq Age Sex Outcome Treatment
    1