BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT G

    MDR report key: 16522288 · Received March 10, 2023

    Report

    Report Number
    3001451226-2023-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    December 1, 2021
    Report Date
    December 19, 2022
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC
    Product Code
    JKA
    UDI-DI
    20612479206070
    PMA / PMN Number
    K123987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER FILED FDA MED WATCH REPORT BACK IN DEC 2021. MCKESSON QA WAS OFFICIALLY NOTIFIED ON SEPT 1ST 2022. I HAVE BEEN TRYING TO GET A PRODUCTION ACCOUTN SINCE OCT 2022. RECEIVED PRODUCTION ACCOUNT 3/8/23. SAFETY DID NOT PROPERLY ENGAGE AFTER IT CLICKED, RESULTING TO NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142618 PREVENT G SAFETY BLOOD COLLECTION SET JKA INNOVATIVE MEDICAL TECHNOLOGIES, INC 16-BC2134 210705 20612479206070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other