BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUGLIDE

    MDR report key: 3975815 · Received June 4, 2014

    Report

    Report Number
    3975815
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 4, 2014
    Manufacturer
    HELIO MEDICAL SUPPLIES
    Product Code
    MQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TO PAIN MANAGEMENT UNIT FOR ELECTROACUPUNCTURE TREATMENT. NEEDLES WERE PLACED AND STIMULATION OF NEEDLE OCCURRED. AT THE END OF THE PROCEDURE ALL NEEDLES WERE REMOVED INTACT EXCEPT FOR ONE. THIS 26-GAUGE, 3CM NEEDLE BROKE OFF AT THE HUB, AND IT WAS SEEN WITH FLUOROSCOPY AT THE TRANSVERSE PROCESS OF L3 ON THE RIGHT. PHYSICIAN ATTEMPTED TO RETRIEVE IT WITHOUT SUCCESS. PATIENT WAS REFERRED TO HOSPITAL FOR SURGICAL REMOVAL UNDER FLUOROSCOPY WHICH WAS SUCCESSFUL.MANUFACTURER RESPONSE FOR ACCUPUNCTURE NEEDLE, ACUGLIDE ACUPUNCTURE NEEDLE MT1/ML1 25X30 MM (PER SITE REPORTER).======================REP MADE AWARE; HAVE NOT HEARD BACK AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326819 ACUGLIDE NEEDLE, ACUPUNCTURE, SINGLE USE MQX HELIO MEDICAL SUPPLIES * 00926003

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER DEVICES BEING USED AT THE TIME OF REMOVAL| OF THE NEEDLE| OTHER