MAUDE Adverse Event Report: PANORAMIC X-RAY; X-RAY, TOMOGRAPHY, COMPUTED, DENTAL

Device Problem Radiation Output Problem (4026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  Injury  

Event Description

My wife was in (b)(6).Before any examination, the dentist vigorously told my wife to take the x-rays because it is safe.My wife reported the pregnancy and it was clearly visible - she is 5+ months she took around 20 exposures + panoramic.Note, my wife had no trauma, she needed filling only because the old filling fall off.I also noted, they have no dose measurement or control and the receptionist is sitting right in front of the x-ray room with no doors.The dose of dental x-rays are relatively low, but it is not zero and also cumulative in human body.Assuming there are no level of safe exposure to radiation, i assume, it is irresponsible behavior from a dental office vigorously inform/ recommend x-ray exposures to pregnant woman.Also, the close exposure from public and receptionists right in front of the room where the panoramic machine is under constant use could go over the public limit dose nationally and internationally defined.Thank you in advance for all your attention to this case.The x-ray exposure was completely unnecessary and it was taken under strong advise of the dentist.Fda safety report id# (b)(4).

• Brand Name: PANORAMIC X-RAY
• Type of Device: X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
• MDR Report Key: 15597701
• MDR Text Key: 301904850
• Report Number: MW5112617
• Device Sequence Number: 1
• Product Code: OAS
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White