BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH - VENTRALEX

    MDR report key: 3032152 · Received March 6, 2013

    Report

    Report Number
    1213643-2013-00083
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. 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. AS REPORTED THE SURGEON BELIEVED HE MAY HAVE APPLIED TOO MUCH FORCE. THE MESH WAS REMOVED FROM THE PT WITH NO PT INJURY. THE USER FACILITY DISCARDED THE DEVICE, THEREFORE AN EVALUATION CANNOT 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: IT WAS REPORTED THAT THE PRODUCT WAS IN GOOD CONDITION WHEN OPENED TO BE USED DURING AN OPEN HERNIA REPAIR. WHEN THE SURGEON ATTEMPTED TO FIXATE THE MESH WITH A NON-BARD FIXATION DEVICE, THE FASTENER PUSHED THROUGH THE MESH, LEAVING A HOLE IN THE MATERIAL. SURGEON REPORTED THAT HE POTENTIALLY HAD USED TOO MUCH PRESSURE. THE MESH WAS REMOVED FROM THE SITE WITHOUT ISSUE AND WAS DISCARDED BY THE FACILITY. THE REPORTED ISSUE DID NOT RESULT IN PT INJURY OR HARM HOWEVER IF A PERFORATED MESH WERE LEFT IN THE BODY IT COULD COMPROMISE THE DEVICE AND POSSIBLY RESULT IN AN ADVERSE PT OUTCOME. AS A RESULT THIS MALFUNCTION IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96560 MESH - VENTRALEX FTL DAVOL INC. NA HUVB1971

    Patients

    Seq Age Sex Outcome Treatment
    1