BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD RECONIX

    MDR report key: 3695453 · Received February 4, 2014

    Report

    Report Number
    1213643-2014-00023
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED SAMPLE FOUND NO ANOMALIES. CONFIRMED DAMAGE AS REPORTED. REVIEW OF THE MANUFACTURING RECORDS SHOWED THAT THE LOT MET SPECIFICATION WHEN RELEASED TO STOCK. AS REPORTED, THIS WAS THE SECOND TIME PRODUCT WAS USED BY HIS SURGEON. AS THIS TIME NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: IT IS ALLEGED DURING A VENTRAL HERNIA REPAIR PROCEDURE, THE RECONIX MESH RIPPED WHEN TRYING TO PLACE A SUTURE. THE SUTURE BEING PLACED WAS EPTFE SUTURE CV-0 TH-50 (NON BARD/DAVOL). THE DEVICE WAS NOT IMPLANTED IN THE PATIENT AND WAS RETURNED FOR EVALUATION. AS THE DAMAGE TO THE MATERIAL COMPROMISED THE IMPLANT AND MDR IS BEING FILED TO DOCUMENT THIS EVENT. AS REPORTED, THERE WAS NOT PATIENT INJURY AND THE DEVICE WAS REMOVED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72612 BARD RECONIX FTL DAVOL INC., SUB. C.R. BARD, INC. BRXF0010

    Patients

    Seq Age Sex Outcome Treatment
    1