MAUDE Adverse Event Report: X-RAY

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Radiation Overdose (1510)

Event Date 02/12/2018

Event Type  Injury  

Event Description

My daughter was admitted to (b)(6) on (b)(6) 2018, during her stay of 13 days she had six chest x-rays performed.I expressed my concern for the repeated x-rays, but i was told by health care professionals that they just wanted to see.My daughter was 27 months on the day she was admitted and my concerns for her safety regarding unnecessary radiation exposure were silenced by the attending pediatricians.She seemed to be fully recovered on her f/u visit on (b)(6) 2018, yet another x-ray was ordered auscultation of her chest appearing normal and clear.I asked if another x-ray was necessary and i was advised that it was just to make sure.I am unsure of what kind of damage my daughter could be facing in her life because of the repeated radiation exposure she experienced at (b)(6).

• Brand Name: X-RAY
• Type of Device: X-RAY
• MDR Report Key: 7289261
• MDR Text Key: 100893666
• Report Number: MW5075447
• Device Sequence Number: 1
• Product Code: KPR
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR
• Patient Weight: 11