BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX HERNIA PATCH

    MDR report key: 4100946 · Received September 19, 2014

    Report

    Report Number
    4100946
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    May 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDIUM VENTRALEX ST MESH USED TO REPAIR INCARCERATED UMBILICAL HERNIA ON (B)(6) 2014. SMALL BOWEL OBSTRUCTION DEVELOPED POSTOPERATIVELY. RETURN TO SURGERY REQUIRED ON (B)(6) 2014. SEPRAFILM COATING OF THE VENTRALEX ST MESH WAS ADHERENT TO THE SMALL BOWEL. THE SMALL BOWEL APPEARED TO BE KINKED AT THE POINT OF CONTACT WITH THE MESH. PATIENT DEVELOPED SEPIS AND GI BLEED AFTER SECOND SURGERY. FAMILY REQUESTED NO FURTHER INTERVENTION. PATIENT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583685 VENTRALEX HERNIA PATCH NONE FTL BARD ACCESS SYSTEMS BATCH # 2014-12 HUWB1829

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR