MAUDE Adverse Event Report: UNKNOWN INTRAORAL X-RAYS; SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL

Patient Problems Arrhythmia (1721); Fatigue (1849); Anxiety (2328); Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/10/2023

Event Type  Injury  

Event Description

I am writing to report a thyroid issues event that i believe was caused by dental imaging for implants.Also, i am reaching out to you seeking any information and assistance you can provide that could help me with treatment to resolve the issues quickly.On monday of last week, i had dental imaging for implants that included cbct, panoramic x-rays, cephalometric x-rays, intraoral x-rays, and intraoral scanner.Panmeca and viso were a couple brands i know for sure.(not sure of all the equipment used).Some of the imaging had to be repeated because the images were unclear.After the imaging, during last week, i started experiencing increased symptoms panic attack feelings, heart palpitation, tremors, shaky, weak, unfocused, the mix between hyperthyroidism and hypothyroidism feelings, thyroiditis.This week, i had my thyroid blood tests done, (one week after imaging) and the results showed below-range tsh and t4, high tpo antibodies and reverse t3.These results indicate thyroid dysfunction justifying why i am feeling the way i am.I have a history of autoimmune hypothyroidism and i am under treatment for it.I should have been showing improvements.These results show it trending for the worse.I have never had thyroid test results as bad as this and i have had thyroid issues for over 20 years.I believe this was caused by the dental imaging radiation.I contacted the dental office with my issue, but they only responded that they followed the standard procedures and protocols for their business.They admitted that they did not use a thyroid shield during any of the imaging and said that was standard.They were aware of my medications and thyroid issues.I also contacted my doctor regarding the symptoms and results, but i have not heard back from them yet.I received results from the lab as soon as they were available.If you send any information you have to help me, it would also help my doctor in treating me.There is so little research available for dental imaging and radiation effects on someone with autoimmune hypothyroidism.Thank you in advance for any assistance you can provide to help me.You can respond by email or via the phone number below.Says ng/dl - within range.Reference reports: #mw5119905, #mw5119907, #mw5119908, #mw5119909.

• Brand Name: INTRAORAL X-RAYS
• Type of Device: SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17381035
• MDR Text Key: 319868221
• Report Number: MW5119906
• Device Sequence Number: 1
• Product Code: MUH
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: IRON.; LIOTHYRONINE.; SIMVASTATIN.; ASPIRIN.; CALCIUM.; LEVOTHYROXINE.; METOPROLOL.; MG.; PROBIOTICS.; SELENIUM.; SPIROLACTONE.; THYROID MULTIVITAMINS.; ZINC.
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White