MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. CT SCAN MACHINE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

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

Patient Problems Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Diaphoresis (2452); Weight Changes (2607); Unspecified Nervous System Problem (4426); Unspecified Gastrointestinal Problem (4491); Unspecified Reproductive System or Breast Problem (4513); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2021

Event Type  Injury  

Event Description

I was casually recommended to get a ct scan by a health professional i was told to go see to investigate intermittent kidney/gallbladder area pain, not severe by any means but would flare up from time to time.After the abdomen and pelvic ct scan i became suddenly extremely sick with 50 plus brutal symptoms and problems i never had before that started in the following days, weeks, and months after the radiation exposure.I threw up for 6 months every day, lost 35lbs, was almost completely castrated from what my normal was and all my bodily functions negatively changed as my symptoms were similar to being burned and dehydrated alive.The most brutal torture and agony one could describe.Brutal painful burning sensations developed over my skin and insides after a couple of weeks of severe night sweats, vomiting, and gi dysfunction as the radiation sickness started to set in.Again all new never had before problems that started after the ct.I have a letter i have written and submitted to the fda and ge healthcare that describe my symptoms and injuries more in detail.The medical terms would be mucosal injuries across my organs, nerve damage everywhere and radiation sickness/poisoning.My endocrine system was severely damaged as i was almost completely castrated from what my normal and damage to my male reproductive organs which may be a bit much to describe on this form.There are no forms provided at these facilities to warn against the risks, side affects, nothing.For the significant risks of these scans and zero forms about the risks is unacceptable.This large amount of radiation across my body in a 2 to 3 minute scan brutalized my insides with reduced organ function across my body from what was my normal, even still today a year after the radiation poisoning incident.I live in constant agony, nausea and weakness no matter what i eat or do and my problems were severe for 6 months straight.There has been no accountability or action taken regarding my case other than get over it and hope you get well treatment.I was almost completely castrated at one point from the radiation damage to my testicles alone.Imagine what it did to the rest of my insides across my body.Absolutely brutal and horrific.Radiation poisoning and radiation exposure by these machines is out of control.For these ct scans that involve large amounts of radiation across most of your body and organs in a short amount of time to and for practitioners to casually recommended to investigate non emergency abdomen pain is not only defensive medicine practice but reckless.There is no safety net for the patient with zero forms that are provided that go over the areas being scanned, significant radiation exposure, or the risks.This turns out to be a very dangerous scan for some people and for the fda to not require radiology departments to even provide a simple consent form is unacceptable.It would be fair to say my scan was unnecessary especially when a quality non risk scan like an mri could have been recommended instead to protect my health.These radiology departments, doctors recommending these out of defensive medicine practice in non needed situations are out of control.I have met people that have had negative side affects from these ct scans though not as severe as mine.Do something.Protect the public with requiring a simple consent form.Something because being provided zero consent forms about the areas being scanned and the risks is unacceptable especially when these scans are casually recommend by the medical field.Fda safety report id# (b)(4).

Event Description

I was casually recommended to get a ct scan by a health professional i was told to go see to investigate intermittent kidney/gallbladder area pain, not severe by any means but would flare up from time to time.After the abdomen and pelvic ct scan i became suddenly extremely sick with 50 plus brutal symptoms and problems i never had before that started in the following days, weeks, and months after the radiation exposure.I threw up for 6 months every day, lost 35lbs, was almost completely castrated from what my normal was and all my bodily functions negatively changed as my symptoms were similar to being burned and dehydrated alive.The most brutal torture and agony one could describe.Brutal painful burning sensations developed over my skin and insides after a couple of weeks of severe night sweats, vomiting, and gi dysfunction as the radiation sickness started to set in.Again all new never had before problems that started after the ct.I have a letter i have written and submitted to the fda and ge healthcare that describe my symptoms and injuries more in detail.The medical terms would be mucosal injuries across my organs, nerve damage everywhere and radiation sickness/poisoning.My endocrine system was severely damaged as i was almost completely castrated from what my normal and damage to my male reproductive organs which may be a bit much to describe on this form.There are no forms provided at these facilities to warn against the risks, side affects, nothing.For the significant risks of these scans and zero forms about the risks is unacceptable.This large amount of radiation across my body in a 2 to 3 minute scan brutalized my insides with reduced organ function across my body from what was my normal, even still today a year after the radiation poisoning incident.I live in constant agony, nausea and weakness no matter what i eat or do and my problems were severe for 6 months straight.There has been no accountability or action taken regarding my case other than get over it and hope you get well treatment.I was almost completely castrated at one point from the radiation damage to my testicles alone.Imagine what it did to the rest of my insides across my body.Absolutely brutal and horrific.Radiation poisoning and radiation exposure by these machines is out of control.For these ct scans that involve large amounts of radiation across most of your body and organs in a short amount of time to and for practitioners to casually recommended to investigate non emergency abdomen pain is not only defensive medicine practice but reckless.There is no safety net for the patient with zero forms that are provided that go over the areas being scanned, significant radiation exposure, or the risks.This turns out to be a very dangerous scan for some people and for the fda to not require radiology departments to even provide a simple consent form is unacceptable.It would be fair to say my scan was unnecessary especially when a quality non risk scan like an mri could have been recommended instead to protect my health.These radiology departments, doctors recommending these out of defensive medicine practice in non needed situations are out of control.I have met people that have had negative side affects from these ct scans though not as severe as mine.Do something.Protect the public with requiring a simple consent form.Something because being provided zero consent forms about the areas being scanned and the risks is unacceptable especially when these scans are casually recommend by the medical field.Fda safety report id# (b)(4).

• Brand Name: CT SCAN MACHINE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.
• MDR Report Key: 13472717
• MDR Text Key: 285406107
• Report Number: MW5107244
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White