BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACO

    MDR report key: 15266602 · Received August 22, 2022

    Report

    Report Number
    MW5111629
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 18, 2022
    Manufacturer
    KINOVA
    Product Code
    IQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FATHER OF A 5 YEAR CLIENT FOR THE SUBJECT JACO REPORTED FIRE COMING OUT OF HIS JACO. THIS CLIENT IS VERY ROUGH ON HIS JACO BUT THE FATHER REPORTS THE FIRE OCCURRED WHILE THE JACO WAS NOT MOVING. WE ARE HAVING IT SENT TO OUR OFFICE FOR REVIEW AND WILL ADVISE YOU ONCE WE RECEIVE IT. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A REPORTER ON 9/20/2022 FOR A REPORT NUMBER MW5111629.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331798 JACO HAND, EXTERNAL LIMB COMPONENT, POWERED IQZ KINOVA PJ 00090 0006

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male