BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 2932158 · Received January 22, 2013

    Report

    Report Number
    MW5028715
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 11, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KII BALLOON BLUNT SYSTEM: BALLOON PART OF SYSTEM HAS A HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31638 KII BALLOON BLUNT TIP SYSTEM NONE GCJ APPLIED MEDICAL 1169577

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention