BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII BALLOON BLUNT TIP SYSTEM 12X100MM

    MDR report key: 2172268 · Received July 15, 2011

    Report

    Report Number
    2172268
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 15, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    APPLIED MEDICAL TROCAR WAS DEFECTIVE; PART OF THE BALLOON PEELED OFF. A SECOND DEVICE WAS OPENED TO COMPLETE PROCEDURE.======================MANUFACTURER RESPONSE FOR KII BALLOON BLUNT TIP SYSTEM, KII BALLOON BLUNT TIP SYSTEM 12X100MM (PER SITE REPORTER)======================MANUFACTURER PROVIDED RGA# FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII BALLOON BLUNT TIP SYSTEM 12X100MM KII BALLOON BLUNT TIP SYSTEM GCJ APPLIED MEDICAL C0R47 1138201

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR