BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 10004822 · Received April 27, 2020

    Report

    Report Number
    MW5094280
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 23, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    UDI-DI
    00607915116453
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DO A LAP CHOLE TROCAR, THE BALLOON FAILED. TROCAR WAS REPLACED WITH ANOTHER SIMILAR PRODUCT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467212 KII BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. C0R47 1371001 00607915116453

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention