BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 8138669 · Received December 6, 2018

    Report

    Report Number
    1213643-2018-04441
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    September 2, 2015
    Report Date
    December 6, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031533
    PMA / PMN Number
    K101920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE PATIENT'S POST-OP COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. ADHESIONS ARE KNOWN INHERENT RISKS OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRIO ST (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRIO ST (DEVICE #1). SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: NO SAMPLE RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRIO ST MESH (DEVICE #1) 8CM X 12CM IN DIAMETER, REFERENCE NUMBER 5950030, LOT NUMBER HUVJ0904 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE PREVIOUSLY PLACED INCISIONAL HERNIA MESH (DEVICE #1). DURING THE SURGERY, THE PHYSICIAN NOTICED THAT THERE WERE MULTIPLE ADHESIONS BETWEEN THE OLD MESH AND THE OMENTUM. THERE WERE LOOPS OF SMALL BOWEL THAT WERE ALSO ADHERENT TO THE MESH. THIS NECESSITATED REMOVAL. THE PHYSICIAN ALSO NOTED WAS A RECURRENT INCISIONAL HERNIA AND A BARD/DAVOL VENTRIO ST MESH (DEVICE #2) 11CM X 14CM IN DIAMETER, REFERENCE NUMBER 5950040, LOT NUMBER HUVJ0905 WAS IMPLANTED. ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE PREVIOUSLY PLACED INCISIONAL HERNIA MESH (DEVICE #2). DURING THE SURGERY THE PHYSICIAN NOTED THAT THERE WERE DENSE ADHESIONS TO THE MESH AND OMENTUM. ADHESIONS WERE LYSED AND THEN REMOVED THE MESH (DEVICE #2). IT IS ALLEGED THAT THE VENTRIO ST MESH IMPLANTED (DEVICE #1 AND DEVICE #2) IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PRODUCT CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PRODUCT HAD INITIALLY BEEN IMPLANTED TO TREAT. IT IS ALLEGED THAT THE PATIENT HAS BEEN INJURED. HE HAS SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977586 VENTRIO ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVJ0905 00801741031533

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S