MAUDE Adverse Event Report: CT SCAN; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Radiation Overexposure (3017)

Patient Problem Headache (1880)

Event Date 06/18/2022

Event Type  Injury  

Event Description

Ct scan of brain, i was scanned multiple times at once, each time at a overdose of 15 msv.I was scared at least six times in one sitting at that dose equaling at least 90 msv.I am suffering great side effects and harm.Excruciating pain in my brain constantly, along with other symptoms and getting worse.Fda safety report id# (b)(4).

• Brand Name: CT SCAN
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 15499295
• MDR Text Key: 300899055
• Report Number: MW5112318
• Device Sequence Number: 1
• Product Code: JAK
• 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: 09/25/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic