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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Sensation in Eye (1869); Headache (1880); Rash (2033); Tinnitus (2103); Visual Impairment (2138); Brain Injury (2219); Injury (2348); Numbness (2415); Shaking/Tremors (2515)

Event Date 10/14/2014

Event Type  Injury  

Event Description

Patient went to the hospital for a superficial face injury.Was told face is fine but was asked to have a ct scan.Patient reluctantly went and did the ct scan.He was told by the lab tech that only a little radiation is present.Pt felt a sensation during the ct scan on his back and top of his head.Patient is currently suffering from headaches.Patient has been suffering from headaches for the past three years.Patient is also suffering from high pitch ringing in his ears, vision problem, speech difficulty and balance difficulty.Pt often wake up with numbness in his hands, fingers and sometimes in his arms.Patient worries about paralysis later in life.Patient was diagnosed with peyronie's disease two months after the ct scan.Patient also had red rash by his clavicle area, brown spots on face, tremors, and symptoms that are consistent with brain injury a few weeks after the ct scan.Patient was severely thirsty the day after the ct scan.Patient also had wrinkle on his face a week or two after the ct scan.Patient believes his symptoms after the ct scan is one of the worst in history.Patient thinks he has radiation induced brain injury caused by the ct scan.Patient currently has a court case with the hospital that performed the ct scan.

• Brand Name: LIGHTSPEED CT SCAN MACHINE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE
• MDR Report Key: 6903575
• MDR Text Key: 87856693
• Report Number: MW5072523
• 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: 09/28/2017

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR