BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEHAND

    MDR report key: 512810 · Received February 23, 2004

    Report

    Report Number
    1530440-2004-00002
    Event Type
    Injury
    Date Received
    February 23, 2004
    Date of Event
    January 23, 2004
    Report Date
    February 19, 2004
    Manufacturer
    NEUROCONTROL CORP.
    Product Code
    GZC
    Removal / Correction Number
    Z-0983-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TRANSMIT COIL TO IMPLANT COUPLING IS NON FUNCTIONAL. THIS MAKES HAND GRASP FUNCTION TO BE NONFUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEHAND HAND GRASP NEUROPROSTHESIS GZC NEUROCONTROL CORP. 1060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention