BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX

    MDR report key: 7881198 · Received September 17, 2018

    Report

    Report Number
    1213643-2018-03137
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    October 21, 2016
    Report Date
    September 17, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K021736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE ATTORNEY ALLEGES THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR REMOVAL OF THE BARD/DAVOL VENTRALEX, HOWEVER, THE REASON FOR THE MESH EXPLANT PROCEDURE HAS NOT BEEN SPECIFIED AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. NO SPECIFIC DEVICE ISSUE HAS BEEN ALLEGED, AND NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. INFORMATION IS LIMITED AT THIS TIME; SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: 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." NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT REPAIR OF A SMALL VENTRAL HERNIA. IT IS ALLEGED THAT A BARD/DAVOL VENTRALEX MESH, REFERENCE NUMBER 0010301, LOT NUMBER HUVK0145 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY TO REMOVE THE FAILED BARD/DAVOL VENTRALEX MESH. AS REPORTED,UPON INSPECTION AND REMOVAL OF THE FAILED MESH, THE SURGEON NOTED THAT THE PATIENT HAD ¿GRANULATION TISSUE¿ COMMUNICATING ¿DOWN TO THE AREA OF HIS PREVIOUSLY PLACED MESH.¿ IT IS ALLEGED THAT THE BARD/DAVOL VENTRALEX MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE BARD/DAVOL VENTRALEX MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721417 VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVK0145 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S