MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH MAGNETOM SIEMENS HEALTH CARE IMAGING; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number MAGENTOM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Head Injury (1879); Brain Injury (2219)

Event Date 04/12/2020

Event Type  Injury  

Event Description

I was basically in the hospital building, (b)(6).I was under the influence of drugs, and had been laid under an mri cat rad radiology machine called a siemens.This was the sixth time (6 times) this had happened to myself (b)(6).I underwent severe traumatic and permanent brain injuries and damage from this doctor whom forcefully scanned me in the brain or skull x rays with the siemens.It was neurologist (b)(6) and (b)(6) and (b)(6).We believe (b)(6) or (b)(6) was the causal nurse.It was an mri machine called siemens health care devices or rad or mri or cat scans.This was (b)(6)'s sixth and final brain scan.She was never to speak, talk, read a book or drive a car ever again.She could not attend work or school with others.She was of severe brain damage and injury and could barely function.She could barely speak, had trouble thinking, and could not ever see the light of a school or workplace again.(b)(6) owns a device called a magnetom mri cat radiology device by siemens healthcare the device not only caused me severe brain damage, but also scanned by breasts or underparts like someones private areas or sexual regions were radiated or scanned like if a sex area or breast region or top of the chest was radiated in (b)(6).This could cause radiologic cancers and ruin the body.Fda safety report id # (b)(4).

• Brand Name: MAGNETOM SIEMENS HEALTH CARE IMAGING
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 13010963
• MDR Text Key: 282384939
• Report Number: MW5106040
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2020
• Device Model Number: MAGENTOM
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ABILIFY; HERBAL REMEDIES; INVEGA; PROLIXIN
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Life Threatening
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White