BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEUROLINE CONCENTRIC NEEDLE

    MDR report key: 11957548 · Received June 8, 2021

    Report

    Report Number
    1220828-2021-00004
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 17, 2021
    Manufacturer
    AMBU A/S
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE NEEDLE HEAD HAS BEEN DETACHED DURING THE EMG SCAN AND THE NEEDLE WAS STUCK IN THE PATIENT. THE PATIENT HAD ANOTHER SURGERY SCHEDULED AND THAT WAS WHEN THE DOCTOR REMOVED THE NEEDLE EMBEDDED INSIDE THE PATIENT. THE DOCTOR KNEW WHERE THE NEEDLE WAS AFTER AN X-RAY WAS MADE. THE SURGERY WAS OVERNIGHT AND THE NEEDLE WAS INSIDE THE PATIENT FOR A FEW HOURS. IT WAS LOCATED BETWEEN THE HIP AND GLUTEAL MUSCLE UNDER THE SKIN - IT WAS HIDDEN UNDER THE EPIDERMIS. THE PATIENT IS IN VERY GOOD CONDITION AND THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850187 AMBU NEUROLINE CONCENTRIC NEEDLE CONCENTRIC NEEDLE, NEEDLE ELECTRODE GXZ AMBU A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention