MAUDE Adverse Event Report: X-RAY MACHINE; SYSTEM, X-RAY, TOMOGRAPHIC

Device Problem Vibration (1674)

Patient Problem Increased Sensitivity (4538)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

I attended my chiropractor (b)(6) in (b)(6) this march and they asked me if i would get an x-ray to update my 15 year old records.I hesitantly consented but noticed something strange when every time they shot the x-ray at my exposed torso i actually felt the air vibrate around me.I distinctly remember this because i have never felt a physical sensation from an x-ray before and this series made the hair on my body tingle for a short moment every single time they took a shot.I found this troubling and tried to research if this was normal.According to the (b)(6) this sensation is a sign of a potentially dangerous misuse of an x-ray device and should be reported somewhere, so i thought it would be worth reporting it to you.Please let me know if i should do anything about this for my own health.I think i ignored it for a while because i hoped it was normal but it was very strange and the memory has stuck with me since.Fda safety report id # (b)(4).

• Brand Name: X-RAY MACHINE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHIC
• MDR Report Key: 11893440
• MDR Text Key: 253479153
• Report Number: MW5101585
• Device Sequence Number: 1
• Product Code: IZF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 74