BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX9000

    MDR report key: 22126344 · Received June 2, 2025

    Report

    Report Number
    MW5170963
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    November 11, 2024
    Report Date
    May 25, 2025
    Manufacturer
    EXCITE MEDICAL OF TAMPA BAY LLC
    Product Code
    ITH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS FROM THE DRX9000 MACHINE. IT PULLED MY NECK AND CAUSED SEVERE RADIATING PAIN DOWN MY ENTIRE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717721 DRX9000 EQUIPMENT, TRACTION, POWERED ITH EXCITE MEDICAL OF TAMPA BAY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Life Threatening "CLOANAPRNE".| GABAPENTIN.| NAPROXEN.| TIZANIDINE.