BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM

    MDR report key: 7288418 · Received February 22, 2018

    Report

    Report Number
    7288418
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 14, 2018
    Manufacturer
    DAVOL INC.
    Product Code
    OQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS SUPPOSED TO INFLATE THE MESH AGAINST THE ABDOMINAL WALL TO BE SECURED. THE BALLOON FAILED TO INFLATE SO SURGICAL TEAM THEN HAD TO MANUALLY PLACE MESH AGAINST THE ABDOMINAL WALL TO BE TACKED INTO PLACE. REP WAS NOTIFIED. SURGEON MANUALLY PLACED MESH AGAINST THE ABDOMINAL WALL TO BE TACKED INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132105 VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM MESH, SURGICAL, DEPLOYMENT BALLOON OQL DAVOL INC. 5955600 HUBY0019

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR