BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII

    MDR report key: 4493940 · Received December 23, 2014

    Report

    Report Number
    4493940
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 21, 2014
    Report Date
    December 23, 2014
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED HASSAN TROCAR (REF: C0R47) AND REPORTED THAT THE BALLOON DEFLATED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847952 KII TROCAR GCJ APPLIED MEDICAL RESOURCES CORP. * 1224710

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR
    2 *