MAUDE Adverse Event Report: DENTAL X RAY (DIGITAL I AM TOLD); NONE

Device Problems Use of Device Problem (1670); Protective Measures Problem (3015)

Patient Problems Diarrhea (1811); Fatigue (1849); Pain (1994); Dizziness (2194); Radiation Sickness Syndrome (2256)

Event Date 08/10/2015

Event Type  Injury  

Event Description

I went for a routine cleaning to my dentist office dr (b)(6).I have been going there for years.They took routine xrays and due to some intermittent pain of my l front tooth the hygienist took 3 images positioning the cone above my nose and down towards my chin.She had to repeat 3x as she was not able to get a "good angle".She did not place a thyroid guard or apron over me.I went home and throughout the day, experienced pins and needles sensation on my neck and chest area.I was busy about my day but by evening decided to shower and scrub that area just in case i had a reaction to something in the bib around my neck.My symptoms worsened and it occurred to me that this may be more serious, maybe i was exposed to too much radiation.I called in the a.M.The receptionist said she would have the dr call me and suggested i see my medical dr.I set up an appt with dr (b)(6) @ 1315.Just before my appt time, (b)(6) called back to say it is impossible to have this type of rxn from their xray machine and aprons and thyroid guards are not necessary as they emit such a negligible amt of radiation.She reinforced need to see my physician which i did.More and more symptoms presented, thickness in my chin and neck/chest area, diarrhea, dizziness, fatigue.All reported to my dr.She examined me and felt i might very well be suffering from a mild case of radiation sickness.She drew cbc, cmp, wanted to rpt in 1 wk and do a complete thyroid exam in 3 mos.That day my symptoms continued and progressed to include fever, chills, more diarrhea, nausea, dizziness and continued pins and needles now including back of neck and upper back.I reported this change to the dr who consulted with a toxicologist.They agree there was no tx that could benefit me by this time and informed me they were reporting the incident to (b)(6) and would be calling the dr's ofc to let them know this was happening.She said the cbc and bmp were fairly good and to continue with rpt cbc, cmp in 1 wk and thyroid check in 3 mos.My concern is for my health as the dr told me this exposure could significantly increase my risk of developing cancers in the future.Symptoms could clear up and worsen over a long period of time and there is no way to measure exactly how much radiation i was exposed to.I do not want someone else to go through this and fell the dentist office should have offered me a collar/apron to protect my thyroid instead of taking the xrays over and over without protection knowing there was a risk involved to the pt.I continue to feel very poorly, have been unable to work and am terribly concerned about my prognosis.Since the dental office denies any possibility of their equipment causing any kind of problem, i was never able to ask any questions about the make/model/settings, etc.

• Brand Name: DENTAL X RAY (DIGITAL I AM TOLD)
• Type of Device: NONE
• MDR Report Key: 5019054
• MDR Text Key: 23697236
• Report Number: MW5055621
• Device Sequence Number: 1
• Product Code: MUH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 54