BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 8143425 · Received December 7, 2018

    Report

    Report Number
    1213643-2018-04483
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    December 16, 2016
    Report Date
    December 7, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031472
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE PATIENT'S POST-OP COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SAMPLE WAS RETURNED FOR EVALUATION. 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. NOTE: NO SAMPLE RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2016: THE PATIENT UNDERWENT REPAIR OF AN EPIGASTRIC HERNIA WITH IMPLANT OF A BARD/DAVOL VENTRALEX ST MESH, REFERENCE NUMBER 5950007, LOT NUMBER HUZJ1083. ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY TO REMOVE THE BARD/DAVOL VENTRALEX ST MESH AND REPAIR A RECURRENCE OF PATIENT'S HERNIA DEFECT. DURING THE SURGERY THE PHYSICIAN NOTED THAT "THE PREVIOUS REPAIR ALSO SHOWS EVIDENCE OF RECURRENCE WITH MULTIPLE SMALL HERNIA DEFECTS OVER FOR 3-4CM AREA. THE MESH IS PALPABLE AND IS COMING UP THROUGH THE HERNIA DEFECT." AS ALLEGED BY THE PATIENT'S ATTORNEY, THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE VENTRALEX ST MESH. SHE CONTINUES TO HAVE PROBLEMS INCLUDING PAIN AND NAUSEA. PATIENT HAS BEEN INJURED. SHE HAS SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983051 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZJ1083 00801741031472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S