MAUDE Adverse Event Report: X-RAY MACHINE ; UNIT, X-RAY INTRAORAL

Device Problem Output Problem (3005)

Patient Problems Nerve Damage (1979); Pain (1994); Burning Sensation (2146)

Event Date 07/19/2018

Event Type  Injury  

Event Description

I went to (b)(6) oral and maxillofacial surgery for a dentist appt on (b)(6) 2018.The dentist examined my mouth and asked his dental tech to take my x-ray.I was not provided with a lead apron and it didn't come to mind until after my x-ray was taken.Later that night, the right side of my mouth both upper and lower jaw felt as if it was burning.My teeth were and still are in excruciating pain.I had to treat myself with cold salt water.I reported the problem to the dentist who confirmed that in rare cases of pts who've had worked done to the mouth could potentially experience pain.He went on to explain that the pain is not from the x-ray machine itself but from the radiation.The dentist suggested for me to see a neurologist as this was a nerve problem and he could not give me pain relief medicine to stop the throbbing.I had to rush to mount sinai emergency room.Due to the weekend, i wasn't able to find a neurologist so i wen to my primary care physician who provided me with the same pain medicine that was given to me in the emergency room.I finally saw the neurologist who ruled out that it was a nerve pain.She suggested that i see a dentist because she believed that it was a tooth problem.I made an appt with (b)(6) dental care, (b)(6).The dentist and oral surgeon played down that an x-ray or radiation could ever cause anyone any problems.The surgeon said in order to determine the problem she need to take an x-ray.I provided her with my x-ray that was only taken a week ago.She said that would do her no good.I told her that i was afraid of taking another x-ray and make the matter worse.She walked out of the office and ended our visit with no further advice.I do realize that x-rays help physicians determine the problem but what i don't understand is that why can't a physician use an x-ray that was only taken a week ago.She didn't even bother looking at it to see if it was helpful.There should be a universe x-ray bank where a pt's x-rays can be accessible anywhere, from any hospital or dental office.This would avoid the unnecessary repeating of x-rays.Also, i know first hand that some offices don't provide lead aprons to protect the pt.Pts should also be made aware of the level of radiation that the tech is using and it should be indicated on the x-ray along with the date, name, and office for future reference.I believe that the dentist used an old x-ray machine and cranked up the dose level of radiation to high which caused this pain that i am currently experiencing.

• Brand Name: X-RAY MACHINE
• Type of Device: UNIT, X-RAY INTRAORAL
• MDR Report Key: 7762553
• MDR Text Key: 116642054
• Report Number: MW5078938
• Device Sequence Number: 1
• Product Code: EAP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 95