BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOJECT

    MDR report key: 8154542 · Received December 12, 2018

    Report

    Report Number
    8154542
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    December 4, 2018
    Report Date
    December 6, 2018
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    UDI-DI
    00382830042420
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE TO INJECT BOTULINUM TOXIN IN THE RIGHT MEDIAL HAMSTRING THE NEEDLE BROKE REQUIRING SURGICAL INTERVENTION TO RETRIEVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993669 BOJECT ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH IKT NATUS MANUFACTURING LIMITED 9013S0422 1803LL04 00382830042420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other