BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 7560652 · Received June 1, 2018

    Report

    Report Number
    1213643-2018-01763
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 21, 2015
    Report Date
    June 1, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031755
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE BARD/DAVOL VENTRALIGHT ST W/ECHO DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THE PATIENT UNDERWENT REMOVAL OF THE VENTRALIGHT ST W/ECHO DEVICE AND THE DOCTOR NOTED UPON ENTERING THE PATIENT'S ABDOMEN "DENSE ADHESIONS OF OMENTUM TO THE UNDERLAY MESH". NO MEDICAL RECORDS HAVE BEEN PROVIDED; HOWEVER, ADHESIONS ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. 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: ON (B)(6) 2013: THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR. A BARD/DAVOL VENTRALIGHT ST W/ECHO, REFERENCE NUMBER 5955680, LOT NUMBER HUXA0756 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD/DAVOL VENTRALIGHT ST W/ECHO. AS REPORTED, UPON ENTERING THE PATIENT'S ABDOMEN, THE SURGEON NOTED "IMMEDIATELY APPARENT WERE DENSE ADHESIONS OF OMENTUM TO THE UNDERLAY MESH." AS REPORTED, THE SURGEON SPENT APPROXIMATELY ONE HOUR LYSING THE DENSE ADHESIONS FROM THE BARD/DAVOL VENTRALIGHT ST W/ECHO. AS ALLEGED, THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE BARD/DAVOL VENTRALIGHT ST W/ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404532 VENTRALIGHT ST W/ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXA0756 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S