BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR CLOSURE/SUTURE GRASPER

    MDR report key: 7412682 · Received April 10, 2018

    Report

    Report Number
    3009889060-2018-00002
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BEILUN PLASTECH INC
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TROCAR CLOSURE/SUTURE GRASPER DEVICE CAME APART DURING THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254169 TROCAR CLOSURE/SUTURE GRASPER SUTURE GRASPER CLOSURE HCF BEILUN PLASTECH INC 004170803

    Patients

    Seq Age Sex Outcome Treatment
    1